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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 is a Phase 2 study that has completed, run by Talphera. The registered enrollment target is 88 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00718081
The ClinicalTrials.gov registry entry for NCT00718081 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Talphera, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00718081 reports 0 study locations.
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.
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