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A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia

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NCT00599638

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Huntsville, Alabama, 35801 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

- Male or female of non-childbearing potential

- Pain present for more than 3 months after healing of herpes zoster skin rash

- VAS score of >=40mm at screening and baseline visits

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

- Patients with pain conditions which might impair the assessment of postherpetic
neuralgia

- Skin conditions in the affected dermatome that could alter sensation other than
postherpetic neuralgia

- History or diagnosis of DSM IV major depressive disorder

NCT00599638
Pfizer
Completed
A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia

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A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia
A Two Week Double-Blind Placebo-Controlled Crossover Study To Compare The Efficacy And Safety Of A Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Patients With Post-Herpetic Neuralgia
Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. This study will compare the efficacy of pregabalin when administered with an experimental drug PF-00489791, in patients with post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin alone.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Postherpetic Neuralgia
  • Drug: pregabalin
    75mg bid titrating to 150mg bid on day 4
  • Drug: pregabalin/PF-00489791
    Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4
  • Drug: Placebo
    Placebo
  • Active Comparator: 1
    Intervention: Drug: pregabalin
  • Experimental: 2
    Intervention: Drug: pregabalin/PF-00489791
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
December 2008
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female of non-childbearing potential
  • Pain present for more than 3 months after healing of herpes zoster skin rash
  • VAS score of >=40mm at screening and baseline visits

Exclusion Criteria:

  • Patients with pain conditions which might impair the assessment of postherpetic neuralgia
  • Skin conditions in the affected dermatome that could alter sensation other than postherpetic neuralgia
  • History or diagnosis of DSM IV major depressive disorder
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00599638
B0261002
Not Provided
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

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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