PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia
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| ClinicalTrials.gov Identifier: NCT00614705 |
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Recruitment Status
:
Completed
First Posted
: February 13, 2008
Last Update Posted
: May 16, 2011
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Sponsor:
Pfizer
Information provided by:
Pfizer
- Study Details
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- No Results Posted
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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 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
U.S. FDA Resources
| 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
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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 ]
Secondary Outcome Measures
:
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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
| 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 |
Additional Information:
| Responsible Party: | Director, Clinical Trials Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00614705 History of Changes |
| 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:
|
Neuralgia Neuralgia, Postherpetic Pain Neurologic Manifestations |
Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms |