Clinical trial NCT00506610: A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Flexible Escalating -Dose, Pilot Analgesic Efficacy Study of T-62 in Subjects With Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Keywords: Pain
Postherpetic Neuralgia
Neuralgia, Postherpetic
Shingles
Herpes Zoster
Neuropathic Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether T-62 is effective in providing relief of pain that can occur after an individual experiences a shingles outbreak, which is an infection in adults caused by the same virus that causes chicken pox.


Eligibility criteria: Inclusion Criteria:

* Has a clinical diagnosis of Postherpetic Neuralgia (PHN)
* Experiencing pain for at least 3 months after the healing of shingles rash
* Has at least a weekly average pain intensity of equal to or greater than 4 out of 10
* Females must not be pregnant or breastfeeding and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal
* Will not consume grapefruit or grapefruit juice during the study

Exclusion Criteria:

* Has a current acute or unstable chronic disease other than Postherpetic Neuralgia (PHN)
* Has clinically important medical disorder
* Uses certain types of medications for heart conditions
* Unwilling/unable to discontinue use of medications for treatment of neuropathic pain
* Has a history of hypersensitivity to any medication or soy product
* Has liver or kidney disease
* Has asthma that required treatment within the last year
* Has HIV or hepatitis (other than hepatitis A)
* Has a history of alcohol abuse within the past 2 years
* Has a history of (within last 2 years) or currently abuses prescription or illegal drugs

Primary outcomes:
measure: Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale)
timeFrame: During each Treatment Phase Visit
measure: Various pain related assessment
timeFrame: During each Treatment Phase Visit
measure: Clinical Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC ) scores
timeFrame: At each Treatment Phase Visit
Secondary outcomes:
measure: Incidence, intensity, relationship, and seriousness of treatment-emergent AEs by dose and by treatment group.
measure: Treatment-emergent changes in safety assessments
measure: Evaluation of T-62 plasma concentrations
timeFrame: At various timepoints during the study
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Naples
country: United States
facility: Anchor Research Center
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Winston Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Fargo
country: United States
facility: Plains Medical Clinic
state: North Dakota
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Murrells Inlet
country: United States
facility: Crescent Moon Research
state: South Carolina
city: Spokane
country: United States
facility: Odyssey Research
state: Washington
Study officials:
References: