A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak
Primary Purpose
Postherpetic Neuralgia
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
T-62
Sponsored by
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring Pain, Postherpetic Neuralgia, Neuralgia, Postherpetic, Shingles, Herpes Zoster, Neuropathic Pain
Eligibility Criteria
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
Sites / Locations
- Bradenton Research Center
- Anchor Research Center
- Suncoast Clinical Research
- The Center for Clinical Research
- Plains Medical Clinic
- Altoona Center for Clinical Research
- Crescent Moon Research
- Odyssey Research
Outcomes
Primary Outcome Measures
Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale)
Various pain related assessment
Clinical Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC ) scores
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00506610
Brief Title
A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia
Keywords
Pain, Postherpetic Neuralgia, Neuralgia, Postherpetic, Shingles, Herpes Zoster, Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
T-62
Primary Outcome Measure Information:
Title
Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale)
Time Frame
During each Treatment Phase Visit
Title
Various pain related assessment
Time Frame
During each Treatment Phase Visit
Title
Clinical Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC ) scores
Time Frame
At each Treatment Phase Visit
Secondary Outcome Measure Information:
Title
Incidence, intensity, relationship, and seriousness of treatment-emergent AEs by dose and by treatment group.
Title
Treatment-emergent changes in safety assessments
Title
Evaluation of T-62 plasma concentrations
Time Frame
At various timepoints during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bradenton Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Anchor Research Center
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
The Center for Clinical Research
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Plains Medical Clinic
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Crescent Moon Research
City
Murrells Inlet
State/Province
South Carolina
ZIP/Postal Code
29576
Country
United States
Facility Name
Odyssey Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
12. IPD Sharing Statement
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A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak
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