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NCT00718081 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Talphera.
- Completed
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
NCT00718081: Completed Phase 2 study, sponsored by Talphera.
NCT00718081 is a Phase 2 study that has completed, run by Talphera. The registered enrollment target is 88 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00718081, a Phase 2 study, has completed, sponsored by Talphera.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Oral sufentanil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2008-08 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
What the finished NCT00718081 record still lists
NCT00718081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00718081 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00718081 about?
NCT00718081 is a clinical study titled "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". 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 s...
What is the current status of trial NCT00718081?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2008-08. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00718081?
The interventions under investigation include: Placebo (DRUG), Oral sufentanil (DRUG).
Who is sponsoring clinical trial NCT00718081?
This trial is sponsored by Talphera, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00718081's enrollment target sits among peer trials
88 803rd of 2000 higher than 1,191 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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