A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak

Postherpetic Neuralgia Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Flexible Escalating -Dose, Pilot Analgesic Efficacy Study of T-62 in Subjects With Postherpetic Neuralgia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00506610
• Other study ID #: K862-06-2001
• Status: Withdrawn
• Phase: Phase 2
• First received: July 24, 2007
• Last updated: June 6, 2012

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether T-62 is effective in providing relief of pain that can occur after an individual experiences a shingles outbreak, which is an infection in adults caused by the same virus that causes chicken pox.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has a clinical diagnosis of Postherpetic Neuralgia (PHN)

• Experiencing pain for at least 3 months after the healing of shingles rash

• Has at least a weekly average pain intensity of equal to or greater than 4 out of 10

• Females must not be pregnant or breastfeeding and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal

• Will not consume grapefruit or grapefruit juice during the study

Exclusion Criteria:

• Has a current acute or unstable chronic disease other than Postherpetic Neuralgia (PHN)

• Has clinically important medical disorder

• Uses certain types of medications for heart conditions

• Unwilling/unable to discontinue use of medications for treatment of neuropathic pain

• Has a history of hypersensitivity to any medication or soy product

• Has liver or kidney disease

• Has asthma that required treatment within the last year

• Has HIV or hepatitis (other than hepatitis A)

• Has a history of alcohol abuse within the past 2 years

• Has a history of (within last 2 years) or currently abuses prescription or illegal drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• T-62

Locations

Country	Name	City	State
United States	Bradenton Research Center	Bradenton	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Plains Medical Clinic	Fargo	North Dakota
United States	Crescent Moon Research	Murrells Inlet	South Carolina
United States	Anchor Research Center	Naples	Florida
United States	Suncoast Clinical Research	New Port Richey	Florida
United States	Odyssey Research	Spokane	Washington
United States	The Center for Clinical Research	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale)		During each Treatment Phase Visit
Primary	Various pain related assessment		During each Treatment Phase Visit
Primary	Clinical Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC ) scores		At each Treatment Phase Visit
Secondary	Incidence, intensity, relationship, and seriousness of treatment-emergent AEs by dose and by treatment group.
Secondary	Treatment-emergent changes in safety assessments
Secondary	Evaluation of T-62 plasma concentrations		At various timepoints during the study