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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00614705
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : May 16, 2011
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Neuralgia, Postherpetic Drug: PH-797804 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. PH-797804 pharmacokinetics [ Time Frame: Weeks 1, 2, and 4 ]
  2. Patient global impression of change [ Time Frame: Week 4 ]
  3. Neuropathic Pain Symptom Inventory [ Time Frame: Baseline and Weeks 1, 2, and 4 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614705


Locations
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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
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00614705    
Other Study ID Numbers: A6631013
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Pain
Neurologic Manifestations