Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02634788 · ClinicalTrials.gov registry record · Phase 3
Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
A Phase 3 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 322
- Enrollment target
NCT02634788: Completed Phase 3 study, sponsored by INSYS Therapeutics.
NCT02634788 is a Phase 3 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 322 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02634788, a Phase 3 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 322 participants
- Enrollment target
Study Summary
The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual (under the tongue) Spray compared with placebo in participants with postoperative pain after bunionectomy.
Primary Outcome
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the dura
Interventions
- DRUG Placebo
- DRUG Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 322 participants |
| Start Date | 2016-01-29 |
| Est. Completion | 2016-06-24 |
| Phase | Phase 3 |
What the finished NCT02634788 record still lists
NCT02634788 is an interventional study that assigns participants to a tested intervention. The registered 322 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 (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02634788 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02634788 about?
NCT02634788 is a clinical study titled "Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain". The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual (under the tongue) Spray compared with placebo in participants with postoperative pain after bunionectomy.
What is the current status of trial NCT02634788?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 322 participants. The study started on 2016-01-29. Estimated completion is 2016-06-24.
What interventions are being tested in trial NCT02634788?
The interventions under investigation include: Placebo (DRUG), Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT02634788?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02634788's enrollment target sits among peer trials
322 1081st of 2000 higher than 920 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04090359 · 322 participants · Phase 4
Dual Mobility Acetabular Cups in Revision TJA
- NCT04924075 · 322 participants · Phase 2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
- NCT03715933 · 321 participants · Phase 1
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
- NCT05922878 · 321 participants · Phase 2
Study of ALTO-300 in MDD
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI