- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00614705
PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia
May 9, 2011 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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V Region
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Vina del Mar, V Region, Chile, 2520997
- Pfizer Investigational Site
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Moscow, Russian Federation, 123098
- Pfizer Investigational Site
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St. Petersburg, Russian Federation, 194175
- Pfizer Investigational Site
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St. Petersburg, Russian Federation, 194354
- Pfizer Investigational Site
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Yaroslavl, Russian Federation, 150030
- Pfizer Investigational Site
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Cadiz, Spain, 11009
- Pfizer Investigational Site
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Madrid, Spain, 28006
- Pfizer Investigational Site
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Ourense, Spain, 32005
- Pfizer Investigational Site
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Sevilla, Spain, 41013
- Pfizer Investigational Site
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Valencia, Spain, 46014
- Pfizer Investigational Site
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Linkoping, Sweden, 581 85
- Pfizer Investigational Site
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Stockholm, Sweden, 114 54
- Pfizer Investigational Site
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Stockholm, Sweden, 115 22
- Pfizer Investigational Site
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Dnipropetrovsk, Ukraine, 49616
- Pfizer Investigational Site
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Donetsk, Ukraine, 83045
- Pfizer Investigational Site
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Kharkiv, Ukraine, 61052
- Pfizer Investigational Site
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Kharkiv, Ukraine, 61068
- Pfizer Investigational Site
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Kharkiv, Ukraine, 61178
- Pfizer Investigational Site
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Kyiv, Ukraine, 04050
- Pfizer Investigational Site
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Odessa, Ukraine, 65025
- Pfizer Investigational Site
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Simferopol, Ukraine, 95006
- Pfizer Investigational Site
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Solihull, United Kingdom, B91 2JL
- Pfizer Investigational Site
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East Sussex
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Bexhill on Sea, East Sussex, United Kingdom, TN40 1JJ
- Pfizer Investigational Site
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Lancashire
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Blackpool, Lancashire, United Kingdom, FY3 7EN
- Pfizer Investigational Site
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Surrey
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Weybridge, Surrey, United Kingdom, KT15 2BH
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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6 mg dose in oral capsule form, once daily for 28 days
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Placebo Comparator: 2
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oral capsule form, once daily for 28 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale
Time Frame: 4 weeks
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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PH-797804 pharmacokinetics
Time Frame: Weeks 1, 2, and 4
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Weeks 1, 2, and 4
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Patient global impression of change
Time Frame: Week 4
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Week 4
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Neuropathic Pain Symptom Inventory
Time Frame: Baseline and Weeks 1, 2, and 4
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Baseline and Weeks 1, 2, and 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
January 31, 2008
First Submitted That Met QC Criteria
February 12, 2008
First Posted (Estimate)
February 13, 2008
Study Record Updates
Last Update Posted (Estimate)
May 16, 2011
Last Update Submitted That Met QC Criteria
May 9, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6631013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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