Suzetrigine for Stent Pain

Not yet recruiting at 1 trial location
DA
CM
Overseen ByChristopher Magnani, MD, MS, MPhil
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Urologic surgery has advanced with new technologies to allow less invasive management of common afflictions such as kidney stones, these procedures are notoriously painful as the ureter must be dilated to accommodate any instruments, and a ureteral stent is often left following surgery to allow for adequate healing. Unfortunately, stents are poorly tolerated by a significant number of patients, with up to 100% complaining of bothersome pain and 10% of patients with unplanned healthcare visits. Further complicating kidney stone management is the frequency of concurrent chronic kidney disease (CKD) or acute kidney injury (AKI) that prohibits many patients from taking NSAIDs which limits pain management options. There is now a push to treat these patients with multimodal analgesia to provide better care and reduce opioid use. Suzetrigine is a new a first-in-class selective inhibitor of the NaV1.8 sodium channel that functions as a non-opioid analgesic developed to treat acute pain and neuropathic pain. This study assesses the addition of suzetrigine to standard-of-care multimodal analgesia. We hypothesize a demonstrated decrease in opioid use, decrease Emergency Room visits within 30 days, decrease the number of unplanned care encounters.

Are You a Good Fit for This Trial?

This trial is for adults aged 21 to 80 having ureteroscopy (a kidney stone procedure) at BWFH, who can make their own medical decisions. People who regularly use opioids or have major substance abuse issues cannot join.

Inclusion Criteria

I am between 21 and 80 and having ureteroscopy at BWFH by a high-volume surgeon.
I can make my own medical decisions.
I may or may not have had a stent placed before surgery.

Exclusion Criteria

I regularly use opioids or have a history of significant substance abuse.
I am unable to give my own consent for medical decisions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard multimodal analgesia or multimodal analgesia with suzetrigine following ureteroscopic surgery

30 days
Post-operative survey and follow-up visits

Follow-up

Participants are monitored for opioid usage, unplanned care encounters, and patient-reported outcomes

30 days
Surveys and potential clinic visits

What Are the Treatments Tested in This Trial?

Interventions

  • Suzetrigine

Trial Overview

The study compares standard pain management after ureteroscopy with and without a new non-opioid pain medicine called suzetrigine, to see if it reduces opioid use and unplanned healthcare visits.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: suzetrigine with multimodal analgesia pathwayExperimental Treatment1 Intervention
Group II: multimodal analgesia pathway (standard, no suzetrigine)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Vertex Pharmaceuticals Incorporated

Industry Sponsor

Trials
267
Recruited
36,100+
Dr. David Altshuler profile image

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani profile image

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology