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

NCT00506610

Last updated date
Study Location
Bradenton Research Center
Bradenton, Florida, 34205, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postherpetic Neuralgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
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  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Postherpetic Neuralgia
Intervention  ICMJE Drug: T-62
Study Arms  ICMJE 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
Actual Enrollment  ICMJE
 (submitted: June 6, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2007)
60
Study Completion Date  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00506610
Other Study ID Numbers  ICMJE K862-06-2001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pfizer
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP