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

Neuralgia, Postherpetic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614705
• Other study ID #: A6631013
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2008
• Last updated: May 9, 2011
• Start date: April 2008
• Est. completion date: December 2008

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic

Intervention

Drug:
• PH-797804
6 mg dose in oral capsule form, once daily for 28 days
• Placebo
oral capsule form, once daily for 28 days

Locations

Country	Name	City	State
Chile	Pfizer Investigational Site	Vina del Mar	V Region
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	St. Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Russian Federation	Pfizer Investigational Site	Yaroslavl
Spain	Pfizer Investigational Site	Cadiz
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Ourense
Spain	Pfizer Investigational Site	Sevilla
Spain	Pfizer Investigational Site	Valencia
Sweden	Pfizer Investigational Site	Linkoping
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Stockholm
Ukraine	Pfizer Investigational Site	Dnipropetrovsk
Ukraine	Pfizer Investigational Site	Donetsk
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Odessa
Ukraine	Pfizer Investigational Site	Simferopol
United Kingdom	Pfizer Investigational Site	Bexhill on Sea	East Sussex
United Kingdom	Pfizer Investigational Site	Blackpool	Lancashire
United Kingdom	Pfizer Investigational Site	Solihull
United Kingdom	Pfizer Investigational Site	Weybridge	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Chile,  Russian Federation,  Spain,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale		4 weeks	No
Secondary	PH-797804 pharmacokinetics		Weeks 1, 2, and 4	No
Secondary	Patient global impression of change		Week 4	No
Secondary	Neuropathic Pain Symptom Inventory		Baseline and Weeks 1, 2, and 4	No

External Links

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