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Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

NCT02634788 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2017-08-14

Study results available
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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.

Conditions

Interventions

DRUG

Buprenorphine

Buprenorphine sublingual spray delivered via single 100 μL spray

DRUG

Placebo

Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray

Sponsors & Collaborators

  • INSYS Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Giovanni DeCastro · INSYS Therapeutics Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-29
Primary Completion
2016-06-24
Completion
2016-06-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02634788 on ClinicalTrials.gov