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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00506610

First received: July 24, 2007

Last updated: June 6, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 24, 2007
Last Updated Date	June 6, 2012
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (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 ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00506610 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (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 ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak
Official Title ^ICMJE	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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Postherpetic Neuralgia
Intervention ^ICMJE	Drug: T-62
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	0
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00506610
Other Study ID Numbers ^ICMJE	K862-06-2001
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Pfizer
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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