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CompletedNCT00159666Updated Jan 22, 2021

Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia

A Phase 4 interventional study of pregabalin in Post-Herpetic Neuralgia, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 40 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
255
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia

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Conditions studied

  • Post-Herpetic Neuralgia
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In context

Neuralgia

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

This study's enrollment of 255 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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of PHN with pain present for at least three months after the healing of a Herpes Zoster skin lesion.
  • Subjects must have completed the Daily Pain Rating Scale in the electronic diary at least 4 times during screening and have an average daily pain rating score of greater than or equl to 4 during the 7 +/- 3 days prior to randomization (Visit 2).

Exclusion criteria

Exclusion Criteria:

  • History of neurolytic or neurosurgical therapy for PHN.
  • Presence of any severe pain associated with conditions other than PHN that may confound the assessment or self-evaluation of the pain due to PHN.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
255 participants

Interventions

  • Drugpregabalin
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What researchers measure

Primary outcomes

  1. Onset meaningful pain reduction

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Study locations

40 sites
  • Pfizer Investigational Site
    Phoenix, Arizona, United States
  • Pfizer Investigational Site
    Little Rock, Arkansas, United States
  • Pfizer Investigational Site
    Duarte, California, United States
  • Pfizer Investigational Site
    Denver, Colorado, United States
  • Pfizer Investigational Site
    Palm Beach Gardens, Florida, United States
  • Pfizer Investigational Site
    Oak Brook, Illinois, United States
  • Pfizer Investigational Site
    Flowood, Mississippi, United States
  • Pfizer Investigational Site
    Saint Louis, Missouri, United States
  • Pfizer Investigational Site
    Toledo, Ohio, United States
  • Pfizer Investigational Site
    Portland, Oregon, United States
  • Pfizer Investigational Site
    Allentown, Pennsylvania, United States
  • Pfizer Investigational Site
    Houston, Texas, United States
  • Pfizer Investigational Site
    Seattle, Washington, United States
  • Pfizer Investigational Site
    Madison, Wisconsin, United States
  • Pfizer Investigational Site
    Berlin, Germany
  • Pfizer Investigational Site
    Bochum, Germany
  • Pfizer Investigational Site
    Duesseldorf, Germany
  • Pfizer Investigational Site
    Frankfurt, Germany
  • Pfizer Investigational Site
    Goeppingen, Germany
  • Pfizer Investigational Site
    Hamburg, Germany
  • Pfizer Investigational Site
    Hattingen, Germany
  • Pfizer Investigational Site
    Jena, Germany
  • Pfizer Investigational Site
    Nuernberg, Germany
  • Pfizer Investigational Site
    Wiesbaden, Germany
  • Pfizer Investigational Site
    L'Aquila, Italy
  • Pfizer Investigational Site
    Perugia, Italy
  • Pfizer Investigational Site
    Pisa, Italy
  • Pfizer Investigational Site
    Roma, Italy
  • Pfizer Investigational Site
    Leganes, Madrid, Spain
  • Pfizer Investigational Site
    Barcelona, Spain
  • Pfizer Investigational Site
    Granada, Spain
  • Pfizer Investigational Site
    Salamanca, Spain
  • Pfizer Investigational Site
    Sevilla, Spain
  • Pfizer Investigational Site
    Valencia, Spain
  • Pfizer Investigational Site
    Middlesbrough, Cleveland, United Kingdom
  • Pfizer Investigational Site
    Addlestone, Surrey, United Kingdom
  • Pfizer Investigational Site
    Chicester, Sussex, United Kingdom
  • Pfizer Investigational Site
    Glasgow, United Kingdom
  • Pfizer Investigational Site
    Oldham, Lancashire, United Kingdom
  • Pfizer Investigational Site
    Portsmouth, United Kingdom
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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 ↗
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Registry details

Key details

Study ID
NCT00159666
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
First posted
Sep 12, 2005
Start date
Oct 2004
Completion
Jun 2006
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 Nov 2006. You cannot join it, but the record below documents what was studied.

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