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

NCT00614705 | Completed Phase 2

• 1 other identifier: A6631013
• Study Type: interventional
• Target: 80
• Locations: 6 countries
• Sites: 25

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.

Conditions

Neuralgia, Postherpetic

Outcome Measures

Primary Outcomes (1)

• Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale

  4 weeks

Secondary Outcomes (3)

• PH-797804 pharmacokinetics

  Weeks 1, 2, and 4

• Patient global impression of change

  Week 4

• Neuropathic Pain Symptom Inventory

  Baseline and Weeks 1, 2, and 4

Study Arms (2)

1

EXPERIMENTAL

Drug: PH-797804

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PH-797804 DRUG

6 mg dose in oral capsule form, once daily for 28 days

1

Placebo DRUG

oral capsule form, once daily for 28 days

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (25)

Pfizer Investigational Site

Viña del Mar, Región de Valparaíso, 2520997, Chile

Location

Pfizer Investigational Site

Moscow, 123098, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 194175, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 194354, Russia

Location

Pfizer Investigational Site

Yaroslavl, 150030, Russia

Location

Pfizer Investigational Site

Cadiz, Cadiz, 11009, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28006, Spain

Location

Pfizer Investigational Site

Ourense, Ourense, 32005, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41013, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46014, Spain

Location

Pfizer Investigational Site

Linköping, 581 85, Sweden

Location

Pfizer Investigational Site

Stockholm, 114 54, Sweden

Location

Pfizer Investigational Site

Stockholm, 115 22, Sweden

Location

Pfizer Investigational Site

Dnipropetrovsk, 49616, Ukraine

Location

Pfizer Investigational Site

Donetsk, 83045, Ukraine

Location

Pfizer Investigational Site

Kharkiv, 61052, Ukraine

Location

Pfizer Investigational Site

Kharkiv, 61068, Ukraine

Location

Pfizer Investigational Site

Kharkiv, 61178, Ukraine

Location

Pfizer Investigational Site

Kyiv, 04050, Ukraine

Location

Pfizer Investigational Site

Odesa, 65025, Ukraine

Location

Pfizer Investigational Site

Simferopol, 95006, Ukraine

Location

Pfizer Investigational Site

Bexhill-on-Sea, East Sussex, TN40 1JJ, United Kingdom

Location

Pfizer Investigational Site

Blackpool, Lancashire, FY3 7EN, United Kingdom

Location

Pfizer Investigational Site

Weybridge, Surrey, KT15 2BH, United Kingdom

Location

Pfizer Investigational Site

Solihull, B91 2JL, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

PH 797804

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 16, 2011

Record last verified: 2011-05

Locations

SE (3); CL (1); RU (4); ES (5); UA (8); GB (4)