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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 Postoperative Pain, sponsored by Talphera.
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
- 1
- Study location
NCT00612534: Completed Phase 2 study of Postoperative Pain, sponsored by Talphera.
NCT00612534 is a Phase 2 study of Postoperative Pain that has completed, run by Talphera. The registered enrollment target is 94 participants, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00612534, a Phase 2 study of Postoperative 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.
Primary Outcome
SPID-12 is the sum of the pain intensity difference (PID) over the 12 hour time period. A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. The pain score at each assessment time point is subtracted from the baseline pain score (starting point) to provide the total sum score or SPID-12. A higher SPID-12 score is better and indicates a reduction in pain intensity compared to the baseline score. Per protoco
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 |
What the finished NCT00612534 record still lists
NCT00612534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which Sufentanil NanoTab is the first listed.
NCT00612534 reports a single indexed study location in 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: Postoperative 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.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00612534's enrollment target sits among peer trials
94 63rd of 120 higher than 57 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain 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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