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NCT01701362 · ClinicalTrials.gov registry record · Phase 3

Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

Completed
Registry status
Phase 3
Development phase
542
Enrollment target

NCT01701362: Completed Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

NCT01701362 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 542 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01701362, 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
542 participants
Enrollment target

Study Summary

This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.

Primary Outcome

This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.

Interventions

  • DRUG placebo
  • DRUG pregabalin

Trial Details

FieldValue
Enrollment Target 542 participants
Start Date 2012-10
Est. Completion 2015-08
Phase Phase 3

What the finished NCT01701362 record still lists

NCT01701362 is an interventional study that assigns participants to a tested intervention. The registered 542 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 (30% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT01701362 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01701362 about?

NCT01701362 is a clinical study titled "Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain". This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, ma...

What is the current status of trial NCT01701362?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 542 participants. The study started on 2012-10. Estimated completion is 2015-08.

What interventions are being tested in trial NCT01701362?

The interventions under investigation include: placebo (DRUG), pregabalin (DRUG).

Who is sponsoring clinical trial NCT01701362?

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.

How this trial's enrollment target compares

Where NCT01701362's enrollment target sits among peer trials

542 694th of 2000 higher than 1,307 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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Source: ClinicalTrials.gov NCT01701362, the US trial registry maintained by the National Library of Medicine. NCT01701362 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.