A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Flexible Escalating -Dose, Pilot Analgesic Efficacy Study of T-62 in Subjects With Postherpetic Neuralgia
1 other identifier
interventional
N/A
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2007
CompletedFirst Posted
Study publicly available on registry
July 25, 2007
CompletedJune 7, 2012
June 1, 2012
July 24, 2007
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale)
During each Treatment Phase Visit
Various pain related assessment
During each Treatment Phase Visit
Clinical Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC ) scores
At each Treatment Phase Visit
Secondary Outcomes (3)
Incidence, intensity, relationship, and seriousness of treatment-emergent AEs by dose and by treatment group.
Treatment-emergent changes in safety assessments
Evaluation of T-62 plasma concentrations
At various timepoints during the study
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (8)
Bradenton Research Center
Bradenton, Florida, 34205, United States
Anchor Research Center
Naples, Florida, 34102, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Plains Medical Clinic
Fargo, North Dakota, 58104, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Crescent Moon Research
Murrells Inlet, South Carolina, 29576, United States
Odyssey Research
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 24, 2007
First Posted
July 25, 2007
Last Updated
June 7, 2012
Record last verified: 2012-06