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

Postherpetic Neuralgia Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00809679
• Other study ID #: K862-08-2002
• Status: Terminated
• Phase: Phase 2
• First received: December 15, 2008
• Last updated: June 6, 2012
• Start date: December 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• T-62 Dose 1
Capsule dosage form 100 mg bid
• T-62 Dose 2
Capsule dosage form 200 mg bid

Other:
• Placebo
Capsule dosage form placebo bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain scores from baseline to following treatment.		weekly	No
Secondary	General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories)		weekly	Yes
Secondary	Pharmacokinetics		weekly	No