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

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NCT00232141

Last updated on November 14, 2019
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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294 United States
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Contact
1-800-718-1021
[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.

NCT00232141
Pfizer
Completed
Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy

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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 SummaryStudy to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy.
Detailed DescriptionNot 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 DateNovember 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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

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[email protected]

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