Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy

NCT00232141

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections, Peripheral Neuropathy
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

- Subjects with confirmed diagnosis of HIV infection

- HIV-associated neuropathic pain (nerve pain) for at least 3 months prior to study start

- subjects with moderate to severe pain

- subjects on stable HIV and pain medications (some medications are not allowed to be taken while participating in the study).

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


- Pregnant or breast feeding females


- subjects using street drugs or alcohol abusers during the study


- subject's on anti-diabetic medications


- use of neuroregenerative agents or neurotoxic chemotherapeutic agents 3 months prior
to study start and throughout the study


- use of neurotoxic drugs (other than D-drugs) within a month prior to study start and
throughout the study.

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HIV Infections, Peripheral NeuropathyStudy of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy
NCT00232141
  1. Birmingham, Alabama
  2. Phoenix, Arizona
  3. Little Rock, Arkansas
  4. Los Angeles, California
  5. Los Angeles, California
  6. Sacramento, California
  7. San Diego, California
  8. San Francisco, California
  9. Stanford, California
  10. West Hollywood, California
  11. Denver, Colorado
  12. Miami, Florida
  13. Pensacola, Florida
  14. Safety Harbor, Florida
  15. Vero Beach, Florida
  16. West Palm Beach, Florida
  17. Atlanta, Georgia
  18. Honolulu, Hawaii
  19. Chicago, Illinois
  20. Chicago, Illinois
  21. Baltimore, Maryland
  22. Boston, Massachusetts
  23. Springfield, Massachusetts
  24. Saint Louis, Missouri
  25. St. Louis, Missouri
  26. New York, New York
  27. New York, New York
  28. New York, New York
  29. Rochester, New York
  30. Portland, Oregon
  31. Philadelphia, Pennsylvania
  32. Austin, Texas
  33. Dallas, Texas
  34. Dallas, Texas
  35. Dallas, Texas
  36. Dallas, Texas
  37. Dallas, Texas
  38. Longview, Texas
  39. San Antonio, Texas
  40. Seattle, Washington
  41. Milwaukee, Wisconsin
  42. Ponce,
  43. San Juan,
  44. San Juan,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With HIV Neuropathy.
Brief Summary Study to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Peripheral Neuropathy
Intervention  ICMJE
  • Drug: pregabalin
    75mg BID (can be titrated up to 150mg BID on day 4 based on individual response and up to 300mg BID at the end of week 1, visit 3 and end of week 2, visit 4)
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: pregabalin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2009)
302
Original Enrollment  ICMJE
 (submitted: September 30, 2005)
300
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with confirmed diagnosis of HIV infection
  • HIV-associated neuropathic pain (nerve pain) for at least 3 months prior to study start
  • subjects with moderate to severe pain
  • subjects on stable HIV and pain medications (some medications are not allowed to be taken while participating in the study).

Exclusion Criteria:

  • Pregnant or breast feeding females
  • subjects using street drugs or alcohol abusers during the study
  • subject's on anti-diabetic medications
  • use of neuroregenerative agents or neurotoxic chemotherapeutic agents 3 months prior to study start and throughout the study
  • use of neurotoxic drugs (other than D-drugs) within a month prior to study start and throughout the study.
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 Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00232141
Other Study ID Numbers  ICMJE A0081066
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2009

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