Tenapanor for Constipation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests tenapanor as a potential treatment for constipation linked to synucleinopathy, a disorder affecting the nervous system. The study aims to determine if tenapanor can improve bowel movements in participants by comparing it to a placebo (a harmless, inactive substance). It seeks individuals with doctor-confirmed Parkinson's disease who experience fewer than five bowel movements weekly and have constipation issues impacting their daily life. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that tenapanor is likely to be safe for humans?
Research has shown that tenapanor has been tested for safety in people with irritable bowel syndrome with constipation (IBS-C). In these studies, diarrhea was the most common side effect. However, no serious or unexpected safety issues emerged. Other research found that tenapanor was safe for use over a year, with safety results similar to shorter studies. This suggests that tenapanor is generally well-tolerated by patients.12345
Why do researchers think this study treatment might be promising for constipation?
Unlike the standard treatments for constipation, which often include fiber supplements, stool softeners, and laxatives, Tenapanor offers a novel approach. It works by inhibiting the NHE3 transporter in the intestines, which helps to increase water content in the stool, making it easier to pass. This unique mechanism could provide relief without the side effects commonly associated with traditional laxatives. Researchers are excited about Tenapanor because it targets the condition at a cellular level, potentially offering a more effective and gentler option for those suffering from constipation.
What evidence suggests that tenapanor might be an effective treatment for synucleinopathy-associated constipation?
Research has shown that tenapanor, which participants in this trial may receive, effectively relieves constipation symptoms. In studies involving individuals with Irritable Bowel Syndrome with Constipation (IBS-C), tenapanor improved the frequency and ease of bowel movements. It also reduced stomach pain, a common symptom of constipation. Another study found tenapanor to be a promising long-term treatment for constipation. These findings suggest that tenapanor might also help treat constipation linked to synucleinopathy, a condition affecting nerve cells.36789
Who Is on the Research Team?
Richard A. Manfready, MD, AM, FACP
Principal Investigator
Cedar Valley Digestive Health Center
Ravindra Mallavarapu, MD
Principal Investigator
Cedar Valley Digestive Health Center
Harichandana Punukula, PharmD, MS
Principal Investigator
Cedar Valley Digestive Health Center
Are You a Good Fit for This Trial?
This trial is for people aged 50-89 with Parkinson's disease (PD) stages 1-3, experiencing constipation. Participants must not be planning to conceive and should use contraception if applicable. They must have fewer than six bowel movements weekly, with less than three feeling complete, despite using laxatives.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Tenapanor 50 mg or placebo orally twice daily for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tenapanor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedar Valley Digestive Health Center
Lead Sponsor
Ardelyx
Industry Sponsor