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NCT07654296 · ClinicalTrials.gov registry record · Phase 3
Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery
A Phase 3 study, sponsored by Brigham and Women's Hospital.
- Not yet
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
NCT07654296: Clinical Trial Phase 3 study, sponsored by Brigham and Women's Hospital.
NCT07654296 is a Phase 3 study that has not yet begun recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 100 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07654296, a Phase 3 study, has not yet begun recruiting, sponsored by Brigham and Women's Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
Study Summary
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.
Primary Outcome
assessed at post-operative visit
Interventions
- DRUG Suzetrigine
- DRUG multimodal analgesia regimen without suzetrigine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 3 |
What is known before NCT07654296 opens enrollment
NCT07654296 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Suzetrigine is the first listed.
NCT07654296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07654296 about?
NCT07654296 is a clinical study titled "Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery". 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 ...
What is the current status of trial NCT07654296?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2026-08-01. Estimated completion is 2027-03-31.
What interventions are being tested in trial NCT07654296?
The interventions under investigation include: Suzetrigine (DRUG), multimodal analgesia regimen without suzetrigine (DRUG).
Who is sponsoring clinical trial NCT07654296?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07654296's enrollment target sits among peer trials
100 1681st of 2000 higher than 288 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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