## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** K862-08-2002
#### Organization
**Class:** INDUSTRY
**Full Name:** Pfizer
### Status Module
#### Completion Date
**Date:** 2009-06

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2010-06-30

**Type:** ESTIMATED

**Disp First Submit Date:** 2010-06-25
**Disp First Submit QC Date:** 2010-06-25

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-06-08

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-06-06

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2009-06

**Type:** ACTUAL

#### Start Date
**Date:** 2008-12

**Status Verified Date:** 2012-06

#### Study First Post Date
**Date:** 2008-12-17
**Type:** ESTIMATED
**Study First Submit Date:** 2008-12-15
**Study First Submit QC Date:** 2008-12-16
**Why Stopped:** Some patients experienced asymptomatic, transient elevations in liver transaminases
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pfizer

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Postherpetic Neuralgia

**Keywords:**

- Postherpetic neuralgia

- Varicella Zoster

- Shingles

- Neuropathic pain

- Analgesia

- Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 19

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: T-62 Dose 1

**Label:** T-62 100 mg bid

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: T-62 Dose 2

**Label:** T-62 200 mg bid

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- T-62 100 mg bid

**Description:** Capsule dosage form 100 mg bid

**Name:** T-62 Dose 1

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- T-62 200 mg bid

**Description:** Capsule dosage form 200 mg bid

**Name:** T-62 Dose 2

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Placebo

**Description:** Capsule dosage form placebo bid

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in pain scores from baseline to following treatment.

**Time Frame:** weekly

#### Secondary Outcomes

**Measure:** General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories)

**Time Frame:** weekly

**Measure:** Pharmacokinetics

**Time Frame:** weekly

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tucson

**Country:** United States

**State:** Arizona

**Location 2:**

**City:** Westlake Village

**Country:** United States

**State:** California

**Location 3:**

**City:** Bradenton

**Country:** United States

**State:** Florida

**Location 4:**

**City:** Naples

**Country:** United States

**State:** Florida

**Location 5:**

**City:** New Port Richey

**Country:** United States

**State:** Florida

**Location 6:**

**City:** Sunrise

**Country:** United States

**State:** Florida

**Location 7:**

**City:** Tampa

**Country:** United States

**State:** Florida

**Location 8:**

**City:** Lexington

**Country:** United States

**State:** Kentucky

**Location 9:**

**City:** Albuquerque

**Country:** United States

**State:** New Mexico

**Location 10:**

**City:** Winston-Salem

**Country:** United States

**State:** North Carolina

**Location 11:**

**City:** Oklahoma City

**Country:** United States

**State:** Oklahoma

**Location 12:**

**City:** San Antonio

**Country:** United States

**State:** Texas

**Location 13:**

**City:** Spokane

**Country:** United States

**State:** Washington

#### Overall Officials

**Official 1:**

**Affiliation:** King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

**Name:** Robert L. Rolleri, Pharm. D.

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010523

- Term: Peripheral Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

### Condition Browse Module - Browse Leaves

- ID: M12381

- Name: Neuralgia

- Relevance: HIGH

- As Found: Neuralgia

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M26725

- Name: Neuralgia, Postherpetic

- Relevance: HIGH

- As Found: Postherpetic Neuralgia

- ID: M9640

- Name: Herpes Zoster

- Relevance: LOW

- As Found: Unknown

- ID: M5888

- Name: Chickenpox

- Relevance: LOW

- As Found: Unknown

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009437

- Term: Neuralgia

- ID: D000051474

- Term: Neuralgia, Postherpetic

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
