Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
Primary Purpose
Postherpetic Neuralgia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
T-62 Dose 1
T-62 Dose 2
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring Postherpetic neuralgia, Varicella Zoster, Shingles, Neuropathic pain, Analgesia, Pain
Eligibility Criteria
Inclusion criteria (additional criteria apply):
- Diagnosis of PHN made by primary treating physician and is experiencing pain for at least 3 months after the healing of a herpes zoster rash.
- Subject is in general good health.
- Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control or be surgically sterile or post-menopausal. Double barrier methods and abstinence are the only acceptable birth control methods for this study.
Exclusion Criteria (additional criteria apply):
- Subject has a current acute disease or unstable chronic disease other than post herpetic neuralgia.
- Subject has a clinically important history of a medical disorder (particularly cardiovascular, neurological [e.g., diabetic neuropathy], respiratory, or hepato-biliary systems [e.g., Gilbert Syndrome]) that would confound and/or interfere with the safety and efficacy evaluations defined in the protocol.
- Subject is being treated for a medical condition that affects cardiac conduction.
- Subject's plasma alanine aminotransferase (ALT) aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase (AP) values are not within the normal reference ranges.
- Subject has a history of asthma requiring management for reactive airway disease in the last year.
- Subject uses and is unwilling/unable to discontinue use of (A) Lyrica® (pregabalin), Cymbalta® (duloxetine), Neurontin® (gabapentin), topical lidocaine, topical capsaicin, or other medication specifically indicated (i.e., labeled) for the treatment of neuropathic pain, or (B) anticonvulsant medications to control post herpetic neuralgia.
- Subject currently requires anticonvulsant medications to control seizures.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
T-62 100 mg bid
T-62 200 mg bid
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in pain scores from baseline to following treatment.
Secondary Outcome Measures
General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories)
Pharmacokinetics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00809679
Brief Title
Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
Official Title
A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Some patients experienced asymptomatic, transient elevations in liver transaminases
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia.
Detailed Description
Study K862-08-2002 is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia (PHN) and its associated pain. Up to 20 centers in the United States will participate in the trial. Two doses of T-62 and placebo will be evaluated in parallel design. Approximately 130 subjects will be enrolled to complete approximately 100 subjects. Each subject will complete a 7-day Screening Period , a 28-day Treatment Period, and a 14-day Post-Treatment Period. Each subject will complete 8 clinic visits over the course of the study during which procedures and assessments of safety, efficacy, and protocol compliance will be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia
Keywords
Postherpetic neuralgia, Varicella Zoster, Shingles, Neuropathic pain, Analgesia, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T-62 100 mg bid
Arm Type
Experimental
Arm Title
T-62 200 mg bid
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
T-62 Dose 1
Intervention Description
Capsule dosage form 100 mg bid
Intervention Type
Drug
Intervention Name(s)
T-62 Dose 2
Intervention Description
Capsule dosage form 200 mg bid
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Capsule dosage form placebo bid
Primary Outcome Measure Information:
Title
Change in pain scores from baseline to following treatment.
Time Frame
weekly
Secondary Outcome Measure Information:
Title
General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories)
Time Frame
weekly
Title
Pharmacokinetics
Time Frame
weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria (additional criteria apply):
Diagnosis of PHN made by primary treating physician and is experiencing pain for at least 3 months after the healing of a herpes zoster rash.
Subject is in general good health.
Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control or be surgically sterile or post-menopausal. Double barrier methods and abstinence are the only acceptable birth control methods for this study.
Exclusion Criteria (additional criteria apply):
Subject has a current acute disease or unstable chronic disease other than post herpetic neuralgia.
Subject has a clinically important history of a medical disorder (particularly cardiovascular, neurological [e.g., diabetic neuropathy], respiratory, or hepato-biliary systems [e.g., Gilbert Syndrome]) that would confound and/or interfere with the safety and efficacy evaluations defined in the protocol.
Subject is being treated for a medical condition that affects cardiac conduction.
Subject's plasma alanine aminotransferase (ALT) aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase (AP) values are not within the normal reference ranges.
Subject has a history of asthma requiring management for reactive airway disease in the last year.
Subject uses and is unwilling/unable to discontinue use of (A) Lyrica® (pregabalin), Cymbalta® (duloxetine), Neurontin® (gabapentin), topical lidocaine, topical capsaicin, or other medication specifically indicated (i.e., labeled) for the treatment of neuropathic pain, or (B) anticonvulsant medications to control post herpetic neuralgia.
Subject currently requires anticonvulsant medications to control seizures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. Rolleri, Pharm. D.
Organizational Affiliation
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
Country
United States
City
Westlake Village
State/Province
California
Country
United States
City
Bradenton
State/Province
Florida
Country
United States
City
Naples
State/Province
Florida
Country
United States
City
New Port Richey
State/Province
Florida
Country
United States
City
Sunrise
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Spokane
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
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