Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia

NCT00809679

Last updated date
Study Location
Tucson, Arizona, , United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postherpetic Neuralgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

(additional criteria apply):

1. 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.

2. Subject is in general good health.

3. 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

(additional criteria apply):


1. Subject has a current acute disease or unstable chronic disease other than post
herpetic neuralgia.


2. 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.


3. Subject is being treated for a medical condition that affects cardiac conduction.


4. Subject's plasma alanine aminotransferase (ALT) aspartate aminotransferase (AST),
total bilirubin, and alkaline phosphatase (AP) values are not within the normal
reference ranges.


5. Subject has a history of asthma requiring management for reactive airway disease in
the last year.


6. 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.


7. Subject currently requires anticonvulsant medications to control seizures.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postherpetic Neuralgia
Intervention  ICMJE
  • Drug: T-62 Dose 1
    Capsule dosage form 100 mg bid
  • Drug: T-62 Dose 2
    Capsule dosage form 200 mg bid
  • Other: Placebo
    Capsule dosage form placebo bid
Study Arms  ICMJE
  • Experimental: T-62 100 mg bid
    Intervention: Drug: T-62 Dose 1
  • Experimental: T-62 200 mg bid
    Intervention: Drug: T-62 Dose 2
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 1, 2009)
19
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2008)
130
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria (additional criteria apply):

  1. 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.
  2. Subject is in general good health.
  3. 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):

  1. Subject has a current acute disease or unstable chronic disease other than post herpetic neuralgia.
  2. 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.
  3. Subject is being treated for a medical condition that affects cardiac conduction.
  4. Subject's plasma alanine aminotransferase (ALT) aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase (AP) values are not within the normal reference ranges.
  5. Subject has a history of asthma requiring management for reactive airway disease in the last year.
  6. 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.
  7. Subject currently requires anticonvulsant medications to control seizures.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00809679
Other Study ID Numbers  ICMJE K862-08-2002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Robert L. Rolleri, Pharm. D.King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
PRS Account Pfizer
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP