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226 Clinical Trials near Jasper, AL
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerLong-Term Safety of Astegolimab for COPD
Jasper, Alabama
This trial is testing astegolimab, a medication for COPD, in people who have already completed a previous study. The goal is to see if it is safe and effective over a longer period by reducing lung inflammation to improve breathing.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:40 - 90
Key Eligibility Criteria
Disqualifiers:Asthma, Pulmonary Fibrosis, Heart Failure, Others
2000 Participants Needed
Itepekimab for COPD
Jasper, Alabama
Primary Objective:
Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD
Secondary Objectives:
* Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD
* Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD
* Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD
* Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD
* Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40 - 85
Key Eligibility Criteria
Disqualifiers:Asthma, Active Smoking, Heart Disease, Others
Must Be Taking:Inhaled Corticosteroids, Long-acting Beta-agonists
1127 Participants Needed
Fixed Dose Triple vs Dual Combination for COPD
Jasper, Alabama
The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes in the target subject population.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:40+
Sex:Male
Key Eligibility Criteria
Disqualifiers:Pregnancy, Respiratory Disorders, Cardiovascular Conditions, Others
Must Be Taking:Inhaled Maintenance Therapy
3433 Participants Needed
BMS-986278 for Idiopathic Pulmonary Fibrosis
Jasper, Alabama
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:40+
Key Eligibility Criteria
Disqualifiers:Stroke, Heart Failure, Malignancy, Others
Must Be Taking:Pirfenidone, Nintedanib
1185 Participants Needed
Endoscopic Airway Examination for Predicting Intubation Complications
Birmingham, Alabama
Purpose of study: To contrast and compare the Mallampatti test to a comprehensive airway grading test using a rigid 75-degree angle laryngoscope (CPAG) Study Hypothesis: The investigators hypothesize that the CPAG will have greater sensitivity and specificity for predicting difficulty laryngoscopy as compared to the Mallampati test.
The investigators plan to test this hypothesis by comparing the correlation of (a) airway Mallampati airway grading (predicted airway difficulty) versus (b) CPAG view grading and Cormack Laryngoscopy assessment (observed airway difficulty).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Under 18, Unwilling Or Unable Examination
200 Participants Needed
Metformin XR for Preventing Multiple Myeloma
Londonderry, New Hampshire
The purpose of this research is to understand whether the drug metformin could be used in the future to help prevent patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) from developing multiple myeloma.
The names of the study drug involved in this study is:
* Metformin, extended release
* Placebo ( a pill that has no active ingredients)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:High-risk Smoldering Myeloma, Other Malignancy, Pregnancy, Renal Or Liver Failure, Others
Must Not Be Taking:Diabetes Medications, Investigational Agents
60 Participants Needed
Metaxalone for Lower Back Pain
Hoover, Alabama
The goal of this clinical trial is to learn if a modification to metaxalone 640 mg can reduce low back and leg pain. The participants will be 18 to 80 years old, healthy with newly occurring back or leg pain. The main question aims to compare a group taking active treatment and a group taking a look-alike substance containing no active treatment. All participants will answer questions on Day 1, before treatment, and on 7-day after treatment, about:
* Amount and quality of pain
* Interference with physical activity
* Interference with sleep
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Clinically Significant Conditions, Others
Must Not Be Taking:Skeletal Relaxants, Pain Relievers, Cimetidine, MAO Inhibitors
50 Participants Needed
Serplulimab + Chemotherapy for Small Cell Lung Cancer
Birmingham, Alabama
This trial is testing two different treatment combinations for patients with extensive-stage small cell lung cancer who have not received any prior treatment. One group will receive a new drug called Serplulimab along with standard chemotherapy, while the other group will receive an existing drug called Atezolizumab with the same chemotherapy. Both immunotherapy drugs aim to help the immune system fight cancer, and the chemotherapy drugs work by killing cancer cells. Atezolizumab has been shown to improve survival in small-cell lung cancer when combined with chemotherapy, changing the standard first-line therapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Mixed SCLC, Severe Allergy, Myocardial Infarction, Others
Must Not Be Taking:Psychotropic Drugs
200 Participants Needed
Active on Power
Amlitelimab + Topical Corticosteroids for Atopic Dermatitis (AQUA)
Birmingham, Alabama
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy.
The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy.
Study details include:
At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD).
The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up.
The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening and a 36-week randomized double-blind period.
The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 \[RIVER-AD\] study).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Immunosuppression, Malignancies, Transplant, Infections, Others
Must Be Taking:Biologics, Oral JAKi
249 Participants Needed
Active on Power
SEP-363856 for Major Depressive Disorder
Birmingham, Alabama
A Phase 2/3 Trial is designed to evaluate SEP-363856 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, PTSD, Others
900 Participants Needed
Active on Power
CYB003 for Depression
Birmingham, Alabama
The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.
Stay on current meds
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Suicide Risk, Others
Must Be Taking:Antidepressants
330 Participants Needed
Active on Power
ABX-002-2001 for Depression
Birmingham, Alabama
The goal of this clinical trial is to learn if ABX-002 added to an existing antidepressant treatment will benefit depression symptoms in adults with moderate to severe major depressive disorder who have had an inadequate response to their antidepressant. This is a double-blind, placebo-controlled, 2-arm, parallel-group, Phase 2 study, randomized 1:1 (ABX-002: placebo). The study will include the following stages: 1. Screening (approximately 35 days) 2. Treatment period (42 days) 3. Follow-up (2 weeks post treatment)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Epilepsy, Others
Must Be Taking:SSRIs, SNRIs
230 Participants Needed
KarXT for Alzheimer's-Associated Psychosis
Homewood, Alabama
This trial is testing KarXT, a medication, to see if it can prevent psychotic symptoms from returning in people with Alzheimer's Disease. It works by balancing brain chemicals that cause hallucinations and delusions. KarXT has shown positive results in reducing symptoms of schizophrenia.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:55 - 90
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Severe Renal Impairment, Others
Must Be Taking:Cholinesterase Inhibitors, Memantine
380 Participants Needed
Donanemab for Alzheimer's Disease
Homewood, Alabama
This trial is testing donanemab, a medication aimed at helping people with Alzheimer's Disease by removing harmful protein clumps from their brains. Donanemab has shown promise in reducing these harmful proteins in Alzheimer's disease.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:65 - 80
Key Eligibility Criteria
Disqualifiers:Mild Cognitive Impairment, Dementia, Cancer, Others
Must Not Be Taking:Cognitive Enhancers
2996 Participants Needed
Sacubitril-Valsartan for High Blood Pressure
Birmingham, Alabama
Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping blood pressure (BP). These conditions are associated with an increased risk of cardiovascular (CV) events and death. Natriuretic Peptides (NPs) are hormones produced by the heart which directly regulate BP by causing dilation of blood vessels and by removing sodium and water from the body. NPs have a 24-hour day-night rhythm and this controls the day-night rhythm of BP as well. The NP-BP rhythm relationship is broken down in obese individuals. Obese individuals also have lower circulating NP levels. Lower circulating levels of NPs and elevated renin hormone (a part of the Renin-Angiotensin-Aldosterone System \[RAAS\]) at nighttime may contribute to the high nocturnal blood pressure in obese individuals which puts them at a higher risk of developing CV events. This current study seeks to determine the biological implications of chronopharmacology for synchronizing NP-RAAS-based blood pressure therapy with the physiological diurnal rhythms to restore the normal diurnal rhythm of blood pressure in obese individuals.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Diabetes, Stroke, Others
Must Not Be Taking:Hypertension Medications
160 Participants Needed
Non-TNFi Biologics vs Targeted Synthetic DMARDs for Rheumatoid Arthritis
Birmingham, Alabama
This trial is testing advanced medications for RA patients who haven't responded to standard treatments. It compares biologic drugs that target immune proteins and synthetic drugs that block harmful molecules in immune cells. The goal is to see which treatment improves patients' quality of life and daily functioning better. Biologic therapies have notably improved the treatment of RA, making disease remission a realistic goal.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:HIV, Heart Failure, Hepatitis, Others
Must Be Taking:TNFi-biologic
924 Participants Needed
Recombinant Factor VIIa for Hemorrhagic Stroke
Birmingham, Alabama
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. FASTEST Part 2 is an extension of the FASTEST Trial where the subgroups include only those treated within 2 hours with a positive spot sign on a baseline CT angiogram.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Coma, Disability, Thrombosis, Pregnancy, Others
Must Not Be Taking:Anticoagulants, Pro-coagulants, Heparin, Others
350 Participants Needed
Psilocybin for Depression
Birmingham, Alabama
The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Severe Substance Use, Others
Must Be Taking:Antidepressants
240 Participants Needed
Valproic Acid for Traumatic Brain Injury
Birmingham, Alabama
The long-term goal of the clinical trial is to develop effective, safe, and easily administered life-saving treatments for patients with moderate to severe traumatic brain injury (TBI).
Patients with moderate to severe TBI will randomly receive either:
1. Standard of care treatment and normal saline
2. Standard of care treatment and one dose of valproic acid (VPA) at a lower dose or a higher dose
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2, 3
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Hepatitis, Pancreatitis, Renal Insufficiency, Others
432 Participants Needed
CD388 for Flu Prevention
Cullman, Alabama
The purpose of this study is to evaluate how well CD388 works in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, when given as a single dose via 3 subcutaneous (SQ) injections to adult and adolescent participants who are at higher risk of developing influenza complications, and to evaluate the safety and tolerability of CD388, as compared to placebo.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12+
Key Eligibility Criteria
Disqualifiers:Pregnancy, Influenza, Severe CKD, Others
Must Not Be Taking:Zanamivir, Monoclonal Antibodies
6000 Participants Needed
Why Other Patients Applied
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
Gemcitabine + BCG for Bladder Cancer
Birmingham, Alabama
This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Neuroendocrine Carcinoma, Muscle-invasive Cancer, Others
Must Be Taking:BCG
330 Participants Needed
Aspirin for Preterm Birth
Birmingham, Alabama
This is a phase-III multi-center double-blind randomized clinical trial of 1,800 individuals with a history of prior preterm birth at less than 35 weeks gestation who are randomized to either 162 mg aspirin or 81 mg aspirin daily. The study drug will be initiated between 10 and 15 weeks gestation and continued through 36 weeks, 6 days gestation. The primary endpoint is recurrent preterm delivery or fetal death prior to 35 weeks, 0 days gestation.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:14+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Hypertension, Renal Disease, Cardiac Disease, Others
Must Not Be Taking:Anticoagulants, Glucocorticoids
1800 Participants Needed
Oral Tranexamic Acid for Shoulder Replacement Surgery
Birmingham, Alabama
The purpose of this clinical trial is to evaluate the short-term clinical outcomes of patients undergoing total shoulder arthroplasty who receive an extended postoperative course of oral tranexamic acid
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cancer, Stroke, Heart Disease, Others
Must Not Be Taking:Anticoagulants
60 Participants Needed
Daraxonrasib for Non-Small Cell Lung Cancer
Birmingham, Alabama
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Cardiovascular, Lung, Others
Must Not Be Taking:Direct RAS-targeted, Docetaxel
420 Participants Needed
Pelacarsen for Cardiovascular Disease
Birmingham, Alabama
This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Adverse Events, Medical Conditions, Others
Must Not Be Taking:Investigational Drugs
600 Participants Needed
Ofatumumab for Multiple Sclerosis
Birmingham, Alabama
This study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:PML, Hepatitis, Immunodeficiency, Malignancy, Others
Must Not Be Taking:B Cell Therapies
180 Participants Needed
Remibrutinib for Chronic Urticaria
Birmingham, Alabama
This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily \[b.i.d.\] by mouth \[p.o.\]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cardiovascular, Neurological, Psychiatric, Others
Must Be Taking:Second Generation Antihistamines
400 Participants Needed
Remibrutinib for Hidradenitis Suppurativa
Birmingham, Alabama
The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Hepatic Disease, Cardiovascular, Neurological, Others
Must Not Be Taking:Antiplatelets, Anticoagulants
555 Participants Needed
ARD-101 for Prader-Willi Syndrome
Birmingham, Alabama
The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS). It will also teach us about the safety of ARD-101.
The main questions it aims to answer are:
* Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)?
* What medical problems do participants have when taking ARD-101?
Researchers will compare ARD-101 to a placebo (a look-alike substance that contains no drug) to see if ARD-101 works to treat hyperphagia in PWS subjects.
Eligible participants will:
* Take ARD-101 or a placebo every day for 12 weeks.
* Visit the clinic or have a tele-visit once every 2 to 4 weeks during dosing and then have a tele-visit 4 weeks after stopping the ARD-101 or placebo.
* Patients/Caregivers will keep a daily diary.
Participants who complete the study may be eligible to enter an open-label extension study where everyone will receive ARD-101.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:13+
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Cancer, Others
Must Not Be Taking:Weight Agents, Glucocorticoids
90 Participants Needed
Lanreotide for Preventing Surgical Complications in Pancreatic Cancer
Birmingham, Alabama
This phase III trial compares the effect of using lanreotide before surgery to surgery alone in preventing pancreatic fistulas in patients with pancreatic cancer or a pancreatic lesion that could become cancerous. Lanreotide, a type of somatostatin analog similar to somatostatin (a hormone made by the body), and is used to treat certain types of gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. It may help stop the body from making extra amounts of certain hormones, including growth hormone, insulin, glucagon, and hormones that affect digestion. It may also help keep certain types of tumor cells from growing. Patients with pancreatic cancer or pancreatic lesions may undergo surgery to remove parts of the pancreas, also called a distal pancreatectomy. Patients may experience complications after surgery, including pancreatic fistulas. A pancreatic fistula occurs when there is a small leak from the pancreas, causing fluids to collect. This can often lead to infection and other problems. Giving lanreotide before undergoing distal pancreatectomy may be more effective than surgery alone in preventing the development of a pancreatic fistula in patients with pancreatic cancer or a pancreatic lesion that could become cancerous.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Malabsorption Syndrome, Radiation Therapy, PRRT, Others
Must Not Be Taking:Somatostatin Analogues
274 Participants Needed
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