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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 is a Phase 3 study that was terminated before completion, run by INSYS Therapeutics. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02310581
The ClinicalTrials.gov registry entry for NCT02310581 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is INSYS Therapeutics, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02310581 reports 0 study locations.
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.
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