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NCT00612534 · 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 Elective Unilateral Total Knee Replacement
A Phase 2 study of Post Operative Pain, sponsored by Talphera.
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
- 1
- Study location
NCT00612534 is a Phase 2 study of Post Operative Pain that has completed, run by Talphera. The registered enrollment target is 94 participants, below the 235-participant average among 56 other Post Operative Pain trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00612534, a Phase 2 study of Post Operative Pain, has completed, sponsored by Talphera.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate three different dosage strengths of sublingual ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of post-operative pain in subjects following total knee replacement 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 Studied
Interventions
- DRUG Sufentanil NanoTab
- DRUG Placebo NanoTab
Study Locations (1)
North Carolina
- Trio Clinical Research - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2008-03 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00612534
The ClinicalTrials.gov registry entry for NCT00612534 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 235-participant average among 56 other Post Operative Pain trials with a reported enrollment target (60% lower). The listed sponsor is Talphera, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Post Operative Pain appearing as the primary indexed condition, and to 2 interventions - of which Sufentanil NanoTab is the first listed.
NCT00612534 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00612534 about?
NCT00612534 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 Elective Unilateral Total Knee Replacement". The purpose of this study is to evaluate three different dosage strengths of sublingual ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of post-operative pain in subjects following total knee replacement surgery. We hypothesize that subjects receiving placebo will ...
What is the current status of trial NCT00612534?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2008-03. Estimated completion is 2008-10.
What conditions does trial NCT00612534 study?
This clinical trial studies the following conditions: Post Operative Pain.
What interventions are being tested in trial NCT00612534?
The interventions under investigation include: Sufentanil NanoTab (DRUG), Placebo NanoTab (DRUG).
Who is sponsoring clinical trial NCT00612534?
This trial is sponsored by Talphera, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00612534 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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