Evaluating Suzetrigine for Pain Relief After Surgery
A Phase 4, Open-label, Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine As Part of Multimodal Therapy for Acute Pain After Aesthetic or Reconstructive Surgeries
This study is testing if a new pain relief medication called Suzetrigine can help people manage pain better after aesthetic or reconstructive surgery compared to regular opioid treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vertex Pharmaceuticals Incorporated Industry-sponsored |
| Locations | 4 sites (Atlanta, Georgia and 3 other locations) |
| Trial ID | NCT06887972 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness, safety, and tolerability of Suzetrigine (SUZ) as part of a multimodal therapy approach for managing acute postoperative pain in patients undergoing aesthetic or reconstructive surgeries. It is a single-arm, Phase 4 interventional study where participants will receive SUZ to determine its impact on pain management compared to traditional opioid therapies. The study will monitor participants for safety and effectiveness over a specified postoperative period.
Who should consider this trial
Good fit: Ideal candidates are adults with a BMI between 18.0 and 40.0 who are scheduled for aesthetic or reconstructive surgeries requiring postoperative pain management.
Not a fit: Patients who have previously participated in studies involving SUZ or have received Journavx may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-opioid alternative for managing acute postoperative pain, reducing reliance on opioids.
How similar studies have performed: While this approach is relatively novel, similar studies evaluating non-opioid pain management strategies have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Body mass index (BMI) of greater than or equal to (≥)18.0 to less than or equal to (≤) 40.0 kilogram per meter square (kg/m\^2) * Participants scheduled to undergo an aesthetic or reconstructive surgical procedure that would typically be treated with opioid therapy for at least 72 hours postoperatively Key Exclusion Criteria: • Participated in a previous study with SUZ or received Journavx Other protocol defined Inclusion/Exclusion criteria may apply.
Where this trial is running
Atlanta, Georgia and 3 other locations
- Atlanta Center for Medical Research — Atlanta, Georgia, United States (Recruiting)
- HD Research LLC | First Surgical Hospital — Bellaire, Texas, United States (Recruiting)
- Memorial Hermann Village — Houston, Texas, United States (Recruiting)
- JBR Clinical Research — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Medical Information
- Email: medicalinfo@vrtx.com
- Phone: 617-341-6777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.