Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-02-10

Brief Summary

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The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual Spray compared with placebo in participants with postoperative pain after a 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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Lower Dose Fentanyl

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

Fentanyl delivered via sublingual spray

Higher Dose Fentanyl Sublingual Spray

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

Fentanyl delivered via sublingual spray

Placebo

Placebo (matching Fentanyl) delivered via sublingual spray every 4 hours.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo delivered via sublingual spray

Interventions

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Fentanyl

Fentanyl delivered via sublingual spray

Intervention Type DRUG

Placebo

Matching placebo delivered via sublingual 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 to 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