Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia

This study has been terminated.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159640
First received: September 7, 2005
Last updated: March 27, 2007
Last verified: March 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159640

  Hide Study Locations
Locations
Australia, New South Wales
Pfizer Investigational Site
Warrawong, New South Wales, Australia
Pfizer Investigational Site
Westmead, New South Wales, Australia
Australia, Queensland
Pfizer Investigational Site
Kippa Ring, Queensland, Australia
Pfizer Investigational Site
Maroochydore, Queensland, Australia
Australia, South Australia
Pfizer Investigational Site
Bedford Park, South Australia, Australia
Australia, Western Australia
Pfizer Investigational Site
Perth, Western Australia, Australia
Australia
Pfizer Investigational Site
Woodville, Australia
Canada, British Columbia
Pfizer Investigational Site
Kelowna, British Columbia, Canada
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
Pfizer Investigational Site
Sherbrooke, Quebec, Canada
Pfizer Investigational Site
Ste-foy, Quebec, Canada
Canada
Pfizer Investigational Site
Unknown, Canada
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic
Pfizer Investigational Site
Ceske Budejovice, Czech Republic
Pfizer Investigational Site
CZ-Praha 8, Czech Republic
Pfizer Investigational Site
Plzen, Czech Republic
Pfizer Investigational Site
Praha 5, Czech Republic
Netherlands
Pfizer Investigational Site
Arnhem, Netherlands
Pfizer Investigational Site
Breda, Netherlands
Pfizer Investigational Site
Kampen, Netherlands
Pfizer Investigational Site
Roosendaal, Netherlands
Pfizer Investigational Site
Rotterdam, Netherlands
Pfizer Investigational Site
Stadskanaal, Netherlands
Spain
Pfizer Investigational Site
Barcelona, Spain
Pfizer Investigational Site
Granada, Spain
Pfizer Investigational Site
Madrid, Spain
Pfizer Investigational Site
Malaga, Spain
Pfizer Investigational Site
Sevilla, Spain
United Kingdom
Pfizer Investigational Site
Portsmouth, Hants, United Kingdom
Pfizer Investigational Site
Northampton, Northants, United Kingdom
Pfizer Investigational Site
London, United Kingdom
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014