Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia
A Double-Blind Randomized Placebo-Controlled Trial of the Time to Onset of Pain Relief in Subjects With Post Therapeutic Neuralgia (PHN) Treated With Pregabalin (150 - 600 Mg/Day Flexible Optimized Dose or 300 Mg/Day Fixed Dose) or Placebo
1 other identifier
interventional
255
5 countries
40
Brief Summary
The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2004
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedJanuary 22, 2021
November 1, 2006
September 8, 2005
January 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Onset meaningful pain reduction
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
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
St 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
Düsseldorf, Germany
Pfizer Investigational Site
Frankfurt, Germany
Pfizer Investigational Site
Göppingen, Germany
Pfizer Investigational Site
Hamburg, Germany
Pfizer Investigational Site
Hattingen, Germany
Pfizer Investigational Site
Jena, Germany
Pfizer Investigational Site
Nuremberg, 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
Leganés, Madrid, Spain
Pfizer Investigational Site
Barcelona, Spain
Pfizer Investigational Site
Granada, Spain
Pfizer Investigational Site
Salamanca, Spain
Pfizer Investigational Site
Seville, 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
Related Publications (2)
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.
PMID: 28072797DERIVEDMarkman 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.
PMID: 27611736DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
October 1, 2004
Study Completion
June 1, 2006
Last Updated
January 22, 2021
Record last verified: 2006-11