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
Completed · Phase 2 · Has a placebo group
Conditions studied: Major Upper or Lower Abdominal Surgery
In brief
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.
Key facts
- Study ID
- NCT00718081
- Run by
- Talphera, Inc
- People needed
- 88
- Starts
- 2008-08-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2015-01-22
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
Where it is running
- Trio Clinical Research — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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