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

Post-Operative Pain Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for the Treatment of Post-Operative Pain in Patients After Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356588
• Other study ID #: SAP301
• Status: Completed
• Phase: Phase 3
• First received: February 2, 2015
• Last updated: August 7, 2015
• Start date: February 2015
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: AcelRx Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-Operative Pain

Intervention

Drug:
• Sufentanil Tablet 30 mcg

• Placebo Tablet

Locations

Country	Name	City	State
United States	Research Concepts, LLC	Houston	Texas
United States	Victory Medical Center	Houston	California
United States	Lotus Clinical Research	Pasadena	California
United States	Shoals Medical Trials, Inc	Sheffield	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
AcelRx Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-weighted summed pain intensity difference (SPID) over the 12-hour study period (SPID12).		12 hours	No