A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery

Phase 2

Completed

• Conditions: Major Upper or Lower Abdominal Surgery
• Interventions: Drug: Placebo; Drug: Oral sufentanil

• Registration Number: NCT00718081
• Lead Sponsor: Talphera, Inc

Brief Summary

The purpose of this study is to evaluate dosages of ARX-F01 (opioid pain medication) versus a placebo (or sugar pill) for the treatment of post-operative pain in subjects following abdominal surgery. We hypothesize that subjects receiving placebo will have poor pain relief and will drop out of the study sooner and more often than the ARX-F01 treated subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-18
• Study Start: 2008-08
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2013-10-18
• Status Verified: 2014-12
• Results First Submitted QC: 2014-12-18
• Last Update Submitted: 2014-12-18
• Results First Posted: 2015-01-22
• Last Update Posted: 2015-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo	Oral dosage of placebo
1	Oral sufentanil	Oral Sufentanil
2	Oral sufentanil	Oral sufentanil

Primary Outcome Measures

Name	Time	Method
SPID-12	12 hours after surgery	The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The scores after summing could range from -122 to +122. A higher SPID-12 score is better.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Who Responded Very Good or Excellent in Patient Global Evaluation of Pain Relief	Up to 12 hours after surgery	At the end of the 12-hour study period each patient rated their overall pain relief since starting study drug on a 5-point scale: poor, fair, good, very good or excellent.

Trial Locations

Locations (1)

Trio Clinical Research; 🇺🇸 Durham, North Carolina, United States