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Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
This study has been terminated.
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00159640
  Purpose

The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of chronic pain following a shingles infection.


Condition Intervention Phase
Pain
 Drug: PD-217,014
 Phase II

MedlinePlus related topics: Shingles
Drug Information available for: Gabapentin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multi-Center, Randomized, Double Blind, Dose-Response, Placebo And Gabapentin Controlled Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To characterise the effectiveness of PD-217,014 in the treatment of chronic pain. A numerical pain intensity rating scale is used to assess pain and a mean endpoint (week 4) pain score change from baseline is calculated.

Secondary Outcome Measures:
  • - Assess the effect of PD-217,014 on responder rate based on the primary endpoint, mean endpoint sleep interference score and the SF-McGill questionnaire (change from baseline to week 4)

Estimated Enrollment: 315
Study Start Date: February 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have pain present for more than 3 months after the healing of shingles skin rash.
  • Patients at screening must have a score >=40 mm on the pain visual analogue scale.

Exclusion Criteria:

  • Patients with poor renal function.
  • Patients with other severe pain, that may impair the self-assessment of the pain due to shingles.
  • Patients with abnormal electrocardiogram.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159640

  Show 32 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Study ID Numbers: A4451006
Study First Received: September 7, 2005
Last Updated: March 27, 2007
ClinicalTrials.gov Identifier: NCT00159640  
Health Authority: United Kingdom: Department of Health

Study placed in the following topic categories:
Neuralgia, Postherpetic
Signs and Symptoms
Neuromuscular Diseases
Neuralgia
 Gabapentin
Peripheral Nervous System Diseases
Neurologic Manifestations
Pain

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009



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