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

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NCT00159666

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Study Location
Pfizer Investigational Site
Phoenix, Arizona, , United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Post-Herpetic Neuralgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Post-Herpetic NeuralgiaStudy of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia
NCT00159666
  1. Phoenix, Arizona
  2. Little Rock, Arkansas
  3. Duarte, California
  4. Denver, Colorado
  5. Palm Beach Gardens, Florida
  6. Oak Brook, Illinois
  7. Flowood, Mississippi
  8. St. Louis, Missouri
  9. Toledo, Ohio
  10. Portland, Oregon
  11. Allentown, Pennsylvania
  12. Houston, Texas
  13. Seattle, Washington
  14. Madison, Wisconsin
  15. Berlin,
  16. Bochum,
  17. Duesseldorf,
  18. Frankfurt,
  19. Goeppingen,
  20. Hamburg,
  21. Hattingen,
  22. Jena,
  23. Nuernberg,
  24. Wiesbaden,
  25. L'Aquila,
  26. Perugia,
  27. Pisa,
  28. Roma,
  29. Leganes, Madrid
  30. Barcelona,
  31. Granada,
  32. Salamanca,
  33. Sevilla,
  34. Valencia,
  35. Middlesbrough, Cleveland
  36. Addlestone, Surrey
  37. Chicester, Sussex
  38. Glasgow,
  39. Oldham, Lancashire,
  40. Portsmouth,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia
Official Title  ICMJE 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
Brief Summary The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Post-Herpetic Neuralgia
Intervention  ICMJE Drug: pregabalin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 8, 2005)		255
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00159666
Other Study ID Numbers  ICMJE A0081004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP