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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Tucson, Arizona, United States
Contact
1-800-718-1021
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

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

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.

NCT00809679
Pfizer
Terminated
Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia

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Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia
The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postherpetic Neuralgia
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
June 2009
June 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00809679
K862-08-2002
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Robert L. Rolleri, Pharm. D. King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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