PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuralgia, Postherpetic | Drug: PH-797804 Drug: Placebo | Phase 2 |
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 |
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 |
- Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale [ Time Frame: 4 weeks ]
- PH-797804 pharmacokinetics [ Time Frame: Weeks 1, 2, and 4 ]
- Patient global impression of change [ Time Frame: Week 4 ]
- Neuropathic Pain Symptom Inventory [ Time Frame: Baseline and Weeks 1, 2, and 4 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
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 |
Neuralgia Neuralgia, Postherpetic Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Pain Neurologic Manifestations |