A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	July 24, 2007
Last Updated Date	November 9, 2007
Start Date ^†
Current Primary Outcome Measures ^† (submitted: July 24, 2007)	Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale) [ Time Frame: During each Treatment Phase Visit ] Various pain related assessment [ Time Frame: During each Treatment Phase Visit ] Clinical Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC ) scores [ Time Frame: At each Treatment Phase Visit ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00506610 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: July 24, 2007)	Incidence, intensity, relationship, and seriousness of treatment-emergent AEs by dose and by treatment group. Treatment-emergent changes in safety assessments Evaluation of T-62 plasma concentrations [ Time Frame: At various timepoints during the study ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	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
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.
Detailed Description
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^†	Postherpetic Neuralgia
Intervention ^†	Drug: T-62
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Withdrawn
Enrollment ^†	60
Completion Date
Primary Completion Date
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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00506610
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	King Pharmaceuticals Research and Development
Collaborators ^††
Investigators ^†
Information Provided By	King Pharmaceuticals Research and Development
Verification Date	November 2007
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.