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NCT01435577 · ClinicalTrials.gov registry record · Phase 2
Intravenous Tapentadol in Post-Bunionectomy Pain
A Phase 2 study of Pain and Bunion, sponsored by Grünenthal.
- Completed
- Registry status
- Phase 2
- Development phase
- 177
- Enrollment target
- 1
- Study location
NCT01435577: Completed Phase 2 study of Pain and Bunion, sponsored by Grünenthal.
NCT01435577 is a Phase 2 study of Pain and Bunion that has completed, run by Grünenthal. The registered enrollment target is 177 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01435577, a Phase 2 study of Pain and Bunion, has completed, sponsored by Grünenthal.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 177 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.
Primary Outcome
Pain Intensity assessed at predefined time points (at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours after first drug administration) over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Pain Intensity Differences at each predefined time point (calculated as post-baseline NRS values - baseline NRS values) were analyzed. Negative SPID24 values indicate a decrease in pain inten
Interventions
- DRUG Matching Placebo
- DRUG Tapentadol
Study Locations (1)
Utah
- Jean Brown Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT01435577 record still lists
NCT01435577 is an interventional study that assigns participants to a tested intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (42% lower).
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Matching Placebo is the first listed.
NCT01435577 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT01435577 about?
NCT01435577 is a clinical study titled "Intravenous Tapentadol in Post-Bunionectomy Pain". The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.
What is the current status of trial NCT01435577?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 177 participants. The study started on 2011-09. Estimated completion is 2012-02.
What conditions does trial NCT01435577 study?
This clinical trial studies the following conditions: Pain, Bunion.
What interventions are being tested in trial NCT01435577?
The interventions under investigation include: Matching Placebo (DRUG), Tapentadol (DRUG).
Who is sponsoring clinical trial NCT01435577?
This trial is sponsored by Grünenthal, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01435577 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01435577's enrollment target sits among peer trials
177 104th of 374 higher than 271 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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