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NCT00442546 · ClinicalTrials.gov registry record · Phase 3
Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 307
- Enrollment target
NCT00442546: Completed Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00442546 is a Phase 3 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 307 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00442546, a Phase 3 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 307 participants
- Enrollment target
Study Summary
Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.
Primary Outcome
The mBPI-SF is a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the Worst Pain item of the m-BPI-sf scale (11 point Likert scale; range: 0 \[no pain\] to 10 \[pain as bad as you can imagine\]), subjects were asked to rate their pain by marking an "X" in one of the ten boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after di
Interventions
- DRUG Placebo
- DRUG pregabalin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2007-05 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
What the finished NCT00442546 record still lists
NCT00442546 is an interventional study that assigns participants to a tested intervention. The registered 307 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00442546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00442546 about?
NCT00442546 is a clinical study titled "Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement". Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.
What is the current status of trial NCT00442546?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 307 participants. The study started on 2007-05. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00442546?
The interventions under investigation include: Placebo (DRUG), pregabalin (DRUG).
Who is sponsoring clinical trial NCT00442546?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00442546's enrollment target sits among peer trials
307 1115th of 2000 higher than 886 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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