PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00614705
First received: January 31, 2008
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

This is a proof-of-concept study to determine if PH-797804 reduces neuropathic pain associated with post-herpetic neuralgia. Suitable patients will be randomized to receive either PH-797804 or placebo for 4 weeks, during which time they will also record their pain symptoms using various pain scales.


Condition Intervention Phase
Neuralgia, Postherpetic
Drug: PH-797804
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Four Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2A Study Of PH-797804 In The Treatment Of Post-Herpetic Neuralgia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PH-797804 pharmacokinetics [ Time Frame: Weeks 1, 2, and 4 ] [ Designated as safety issue: No ]
  • Patient global impression of change [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Neuropathic Pain Symptom Inventory [ Time Frame: Baseline and Weeks 1, 2, and 4 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: April 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PH-797804
6 mg dose in oral capsule form, once daily for 28 days
Placebo Comparator: 2 Drug: Placebo
oral capsule form, once daily for 28 days

  Eligibility

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

Inclusion Criteria:

  • Male or female, at least 18 years of age
  • Patients must have pain present for more than 3 months after healing of the Herpes zoster skin rash. There is no upper limit on the duration of PHN.
  • Patients at screening visit (V1) must have a score ≥40 mm on the Pain Visual Analog Score (VAS).

Exclusion Criteria:

  • Patients having other severe pain, which may impair the self-assessment of the pain due to post-herpetic neuralgia
  • History within the previous year of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, New York Heart Association (NYHA) Class III-IV congestive heart failure requiring treatment, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
  • Tuberculosis without treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative) without known (documented) vaccination with the bacilli Calmette-Guerin vaccine (BCG).
  • A positive approved immunoassay/ELISA blood test for TB (e.g. TB T-SPOT™, QuantiFERON-Gold
  • Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0
  • ECG abnormalities at screening or randomization
  • Evidence of organ dysfunction or hematopoietic disorder
  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: NCT00614705

Locations
Chile
Pfizer Investigational Site
Vina del Mar, V Region, Chile, 2520997
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 123098
Pfizer Investigational Site
St. Petersburg, Russian Federation, 194175
Pfizer Investigational Site
St. Petersburg, Russian Federation, 194354
Pfizer Investigational Site
Yaroslavl, Russian Federation, 150030
Spain
Pfizer Investigational Site
Cadiz, Spain, 11009
Pfizer Investigational Site
Madrid, Spain, 28006
Pfizer Investigational Site
Ourense, Spain, 32005
Pfizer Investigational Site
Sevilla, Spain, 41013
Pfizer Investigational Site
Valencia, Spain, 46014
Sweden
Pfizer Investigational Site
Linkoping, Sweden, 581 85
Pfizer Investigational Site
Stockholm, Sweden, 114 54
Pfizer Investigational Site
Stockholm, Sweden, 115 22
Ukraine
Pfizer Investigational Site
Dnipropetrovsk, Ukraine, 49616
Pfizer Investigational Site
Donetsk, Ukraine, 83045
Pfizer Investigational Site
Kharkiv, Ukraine, 61052
Pfizer Investigational Site
Kharkiv, Ukraine, 61068
Pfizer Investigational Site
Kharkiv, Ukraine, 61178
Pfizer Investigational Site
Kyiv, Ukraine, 04050
Pfizer Investigational Site
Odessa, Ukraine, 65025
Pfizer Investigational Site
Simferopol, Ukraine, 95006
United Kingdom
Pfizer Investigational Site
Bexhill on Sea, East Sussex, United Kingdom, TN40 1JJ
Pfizer Investigational Site
Blackpool, Lancashire, United Kingdom, FY3 7EN
Pfizer Investigational Site
Weybridge, Surrey, United Kingdom, KT15 2BH
Pfizer Investigational Site
Solihull, United Kingdom, B91 2JL
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00614705     History of Changes
Other Study ID Numbers: A6631013
Study First Received: January 31, 2008
Last Updated: May 9, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 July 20, 2014