A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia

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NCT00394901

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Study Location
Pfizer Investigational Site
Nagoya, Aichi, , Japan
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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.
Postherpetic 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

- Visual Analogue Scale (VAS) of pain is higher than 40 mm.

- Pain is sustained for more than 3 months after healing of herpes zoster skin rash.

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


- Malignancy within the past 2 years.


- Patients who have undergone neurolytic or neurosurgical therapy for postherpetic
neuralgia.


- Creatinine clearance and sex using the Cockcroft and Gault equation, by omitting any decimal fractions).


- Patients having other severe pain which may impair the self assessment of the pain due
to postherpetic neuralgia.


- Skin conditions in the affected dermatome that could alter sensation.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia
Official Title  ICMJE A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin In The Treatment Of Postherpetic Neuralgia
Brief Summary The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Neuralgia, Postherpetic
Intervention  ICMJE
  • Drug: Placebo
    placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).
  • Drug: Pregabalin
    Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
  • Drug: Pregabalin
    Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
  • Drug: Pregabalin
    Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Pregabalin 150mg/day
    Intervention: Drug: Pregabalin
  • Experimental: Pregabalin 300mg/day
    Intervention: Drug: Pregabalin
  • Experimental: Pregabalin 600mg/day
    Intervention: Drug: Pregabalin
Publications * Not Provided

*   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
Actual Enrollment  ICMJE
 (submitted: September 24, 2008)		372
Original Enrollment  ICMJE
 (submitted: October 31, 2006)		360
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Visual Analogue Scale (VAS) of pain is higher than 40 mm.
  • Pain is sustained for more than 3 months after healing of herpes zoster skin rash.

Exclusion Criteria:

  • Malignancy within the past 2 years.
  • Patients who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia.
  • Creatinine clearance </= 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation, by omitting any decimal fractions).
  • Patients having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia.
  • Skin conditions in the affected dermatome that could alter sensation.
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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00394901
Other Study ID Numbers  ICMJE A0081120
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
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 February 2010

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