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

  Show 32 Study Locations
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, Postherpetic
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014