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CompletedNCT00301223Updated Jan 22, 2021

A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain

A Phase 3 interventional study of Pregabalin in Neuropathic Pain, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 8 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
309
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The objective of this study is to evaluate the efficacy, safety and tolerability for pregabalin using a flexible, optimized dose schedule compared to placebo in relieving the symptoms of neuropathic pain.

02

Conditions studied

  • Neuropathic Pain

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03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 309 is above the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chinese outpatient of age 18 to 75
  • At screening and baseline, a score of greater than 40 mm on the visual log scale of SF-MPQ

Exclusion criteria

Exclusion Criteria:

  • Neurologic disorders unrelated to neuropathic pain, which in the opinion of the investigator, might impair the assessment of pain
  • Serum creatinine clearance greater than 60 ml/min
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
309 participants (actual)

Interventions

  • DrugPregabalin
06

What researchers measure

Primary outcomes

  1. The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.

Secondary outcomes

  1. The secondary efficacy parameters include the weekly mean pain scores from the subject's daily pain diaries

  2. The Short Form McGill Pain Questionnaire

  3. The Sleep interference score (from subject pain diary)

  4. The Clinician and Patient Global Impression of Change (CGIC and PGIC)

  5. The responder rate defined as the proportion of subjects reporting a decrease of at least 30% in the weekly mean pain scores in each treatment group.

  6. Addtionally, the safety and tolerability of Pregabalin will also be evaluated.

07

Study locations

8 sites
  • Pfizer Investigational Site
    Beijing, China
  • Pfizer Investigational Site
    Cheng Du Si Chaun, China
  • Pfizer Investigational Site
    Guang Zhou, China
  • Pfizer Investigational Site
    Nan Jing, Jiang Su, China
  • Pfizer Investigational Site
    Qing Dao Shan Dong, China
  • Pfizer Investigational Site
    Shang Hai, China
  • Pfizer Investigational Site
    Shanghai, China
  • Pfizer Investigational Site
    Tian Jin, China
08

References and documents

Publications

  • Schug SA, Parsons B, Almas M, Whalen E. Effect of Concomitant Pain Medications on Response to Pregabalin in Patients with Postherpetic Neuralgia or Spinal Cord Injury-Related Neuropathic Pain. Pain Physician. 2017 Jan-Feb;20(1):E53-E63. PubMed 28072797 ↗
  • Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1. PubMed 27611736 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00301223
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party
Sponsor
First posted
Mar 10, 2006
Start date
Feb 2006
Completion
Sep 2007
Last update
Jan 22, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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