Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy
NCT00232141
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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).
- 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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Descriptive Information | ||||
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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 |
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Intervention ICMJE |
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Study Arms ICMJE |
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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 | 302 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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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 |