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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AcelRx Pharmaceuticals, Inc.
• Treatments: Sufentanil

Criteria

Inclusion Criteria (additional criteria not specified here):

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 (additional criteria not specified here):

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.