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NCT02310581 · ClinicalTrials.gov registry record · Phase 3
Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
A Phase 3 study, sponsored by INSYS Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT02310581: Clinical Trial Phase 3 study, sponsored by INSYS Therapeutics.
NCT02310581 is a Phase 3 study that was terminated before completion, run by INSYS Therapeutics. The registered enrollment target is 40 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02310581, a Phase 3 study, was terminated before completion, sponsored by INSYS Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants with moderate to severe postoperative pain after bunionectomy. The study will comprise 4 periods: the Screening Period, the Surgical Period, the Treatment Period, and the Follow-up Period. Participants will be admitted to the study site on the morning of the scheduled surgery, will remain at the study site until postoperative Day 3 (a total of 3 nights at the study site), and will return for the Follow-up Visit 5 to 9 days after surgery.
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 Sublingual Spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-02-24 |
| Est. Completion | 2015-03-19 |
| Phase | Phase 3 |
Why NCT02310581 stopped before completion
NCT02310581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02310581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02310581 about?
NCT02310581 is a clinical study titled "Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain". This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants with moderate to severe postop...
What is the current status of trial NCT02310581?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2015-02-24. Estimated completion is 2015-03-19.
What interventions are being tested in trial NCT02310581?
The interventions under investigation include: Placebo (DRUG), Buprenorphine Sublingual Spray (DRUG).
Who is sponsoring clinical trial NCT02310581?
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 NCT02310581's enrollment target sits among peer trials
40 1878th of 2000 higher than 103 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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