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NCT01057693 · ClinicalTrials.gov registry record · Phase 3
Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 633
- Enrollment target
NCT01057693: Completed Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT01057693 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 633 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01057693, 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
- 633 participants
- Enrollment target
Study Summary
Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.
Primary Outcome
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
Interventions
- DRUG Placebo
- DRUG pregabalin (Lyrica)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 633 participants |
| Start Date | 2010-03-31 |
| Est. Completion | 2012-01-30 |
| Phase | Phase 3 |
What the finished NCT01057693 record still lists
NCT01057693 is an interventional study that assigns participants to a tested intervention. The registered 633 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 (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01057693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01057693 about?
NCT01057693 is a clinical study titled "Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy". Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.
What is the current status of trial NCT01057693?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 633 participants. The study started on 2010-03-31. Estimated completion is 2012-01-30.
What interventions are being tested in trial NCT01057693?
The interventions under investigation include: Placebo (DRUG), pregabalin (Lyrica) (DRUG).
Who is sponsoring clinical trial NCT01057693?
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 NCT01057693's enrollment target sits among peer trials
633 580th of 2000 higher than 1,420 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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