A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-08-31

Brief Summary

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The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain in patients after abdominal surgery.

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Detailed Description

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Conditions

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Post-Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sufentanil Tablet 30 mcg

A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.

Group Type EXPERIMENTAL

Sufentanil Tablet 30 mcg

Intervention Type DRUG

Placebo Tablet

A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.

Group Type PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type DRUG

Interventions

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Sufentanil Tablet 30 mcg

Intervention Type DRUG

Placebo Tablet

Intervention Type DRUG

Other Intervention Names

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ST 30 mcg PT

Eligibility Criteria

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Inclusion Criteria

1. Patients who are scheduled to undergo one of the following procedures with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation:

* abdominoplasty
* open tension-free inguinal hernioplasty (Lichenstein repair with mesh)
* laparoscopic abdominal surgery
2. Patients classified as American Society of Anesthesiologists (ASA) class I - III (Appendix I).
3. Female patients of childbearing potential must be using an effective method of birth control at the time of screening visit
4. Patients who are expected to have moderate-to-severe post-operative pain for at least 24 hours.

Exclusion Criteria

1. Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery
2. Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug.
3. Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).
4. Patients who previously have had abdominoplasty or have had an inguinal hernia repair on the same side.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No