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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-29

Study Completion Date

2016-06-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Buprenorphine 0.5 mg TID

Participants received buprenorphine 0.5 mg sublingual (under the tongue) spray three times daily (TID) for two days.

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

Buprenorphine sublingual spray delivered via single 100 μL spray

Buprenorphine 0.25 mg TID

Participants received buprenorphine 0.25 mg sublingual spray TID for two days.

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

Buprenorphine sublingual spray delivered via single 100 μL spray

Buprenorphine 0.125 mg TID

Participants received buprenorphine 0.125 mg sublingual spray TID for two days.

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

Buprenorphine sublingual spray delivered via single 100 μL spray

Placebo

Participants received placebo-matching buprenorphine sublingual spray TID for two days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Buprenorphine

Buprenorphine sublingual spray delivered via single 100 μL spray

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meets protocol-specified criteria for qualification and contraception
* Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria

* History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

1. the safety or well-being of the participant or study staff;
2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
3. the analysis of results

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No