NCT00718081

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Talphera, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Major Upper or Lower Abdominal Surgery

Interventions

Type	Name	Description
DRUG	Oral sufentanil	Oral dosage of sufentanil
DRUG	Placebo	Oral dosage of placebo

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-07-18
• Last updated: 2015-01-22
• Results posted: 2015-01-22

Locations

1 site across 1 country: United States