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

Primary Purpose

Post-Herpetic Neuralgia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
pregabalin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Herpetic Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Onset meaningful pain reduction

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
January 20, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00159666
Brief Title
Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Herpetic Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
255 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pregabalin
Primary Outcome Measure Information:
Title
Onset meaningful pain reduction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Pfizer Investigational Site
City
Duarte
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Pfizer Investigational Site
City
Palm Beach Gardens
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Oak Brook
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
Flowood
State/Province
Mississippi
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Pfizer Investigational Site
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
Pfizer Investigational Site
City
Berlin
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bochum
Country
Germany
Facility Name
Pfizer Investigational Site
City
Duesseldorf
Country
Germany
Facility Name
Pfizer Investigational Site
City
Frankfurt
Country
Germany
Facility Name
Pfizer Investigational Site
City
Goeppingen
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hattingen
Country
Germany
Facility Name
Pfizer Investigational Site
City
Jena
Country
Germany
Facility Name
Pfizer Investigational Site
City
Nuernberg
Country
Germany
Facility Name
Pfizer Investigational Site
City
Wiesbaden
Country
Germany
Facility Name
Pfizer Investigational Site
City
L'Aquila
Country
Italy
Facility Name
Pfizer Investigational Site
City
Perugia
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pisa
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
Country
Italy
Facility Name
Pfizer Investigational Site
City
Leganes
State/Province
Madrid
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
Country
Spain
Facility Name
Pfizer Investigational Site
City
Granada
Country
Spain
Facility Name
Pfizer Investigational Site
City
Salamanca
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
Country
Spain
Facility Name
Pfizer Investigational Site
City
Middlesbrough
State/Province
Cleveland
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Addlestone
State/Province
Surrey
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chicester
State/Province
Sussex
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Oldham, Lancashire
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Portsmouth
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28072797
Citation
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.
Results Reference
derived
PubMed Identifier
27611736
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081004&StudyName=Study+of+Pregabalin+Therapy+for+Pain+Relief+in+Subjects+with+Post%2DHerpetic+Neuralgia
Description
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Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia

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