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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Nagoya, Aichi, Japan
Contact
1-800-718-1021
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 = 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.

NCT00394901
Pfizer
Completed
A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia

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A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia
A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin In The Treatment Of Postherpetic Neuralgia
The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Neuralgia, Postherpetic
  • 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).
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
372
November 2007
November 2007   (Final data collection date for primary outcome measure)

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
  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00394901
A0081120
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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