Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
NCT ID: NCT01049217
Last Updated: 2021-01-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
377 participants
INTERVENTIONAL
2010-04-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active drug
pregabalin
Pregabalin 75 mg-300mg twice daily during the course of the study.
Control
placebo
Subjects may be assigned to placebo during this study. The study duration is approximately 19 weeks.
Interventions
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pregabalin
Pregabalin 75 mg-300mg twice daily during the course of the study.
placebo
Subjects may be assigned to placebo during this study. The study duration is approximately 19 weeks.
Eligibility Criteria
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Inclusion Criteria
* Documented evidence of HIV-1 infection
* Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with subjective sensory symptom of pain
* Pain starts in the feet
Exclusion Criteria
* Diabetes mellitus requiring regular medical treatment (other than diet and exercise) or HbA1C \>6.9
* Subjects with peripheral neuropathic pain that is not associated with HIV infection; including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy, radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related to: metabolic abnormalities; nutritional factors; vascular insults; inflammation; autoimmune disease; and malignancy
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Southwest Center for HIV/AIDS
Phoenix, Arizona, United States
SW Center for HIV/AIDS
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
AIDS Research Alliance of America
Los Angeles, California, United States
Anthony Mills, MD, Inc.
Los Angeles, California, United States
David Geffen School of Medicine at UCLA c/o NNAB
Los Angeles, California, United States
Providence Clinical Research
North Hollywood, California, United States
Desert Medical Group, Inc. dba Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
University of California San Diego
San Diego, California, United States
Stanford University Medical Center
Stanford, California, United States
Neuroscience Consultants, LLC.
Aventura, Florida, United States
South Florida Medical Research
Aventura, Florida, United States
The Kinder Medical Group
Miami, Florida, United States
Wohlfeiler, Piperato & Associates, LLC
Miami Beach, Florida, United States
Meridien Research
Tampa, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Midtown Neurology, PC
Atlanta, Georgia, United States
Neurology Specialists of Decatur Research Center
Decatur, Georgia, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Mount Sinai School of Medicine
New York, New York, United States
University of Toledo Medical Center
Toledo, Ohio, United States
University of Toledo
Toledo, Ohio, United States
University of Texas Physicians
Bellaire, Texas, United States
Amelia Court HIV Research Clinic
Dallas, Texas, United States
The University of Texas Medical School at Houston
Houston, Texas, United States
Asistencia Cientifica de Alta Complejidad
Bogota, Cundinamarca, Colombia
Centro Instituto de Investigaciones Fundación Universitaria Sanitas
Bogota, Cundinamarca, Colombia
Riesgo de Fractura S.A
Bogotá, Cundinamarca, Colombia
Instituto Colombiano para el Avance de la Medicina- Santander S.A.S. - ICAMEDIC Santander S.A.S
Bucaramanga, Santander Department, Colombia
Instituto Dominicano de Estudios Virológicos - IDEV
Santo Domingo, , Dominican Republic
Mahavir Hospital and Research Centre
Hyderabad, Andhra Pradesh, India
Surakshaka Multispeciality Hospital
Hyderabad, Andhra Pradesh, India
Infectious Disease Clinic
Ahmedabad, Gujarat, India
Jaslok Hospital & Research Centre
Mumbai, Maharashtra, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, India
YR Gaitonde Centre for AIDS Research and Education
Chennai, Tamil Nadu, India
Hospital Nacional Dos de Mayo
Lima, , Peru
Hospital Nacional Guillermo Almenara Irigoyen
Lima, , Peru
Katedra Chorob Zakaznych i Hepatologii UMK w Toruniu CM w Bydgoszczy
Bydgoszcz, , Poland
Oddzial Diagnostyki i Terapii AIDS
Chorzów, , Poland
Ponce School of Medicine-CAIMED Center
Ponce, PR, Puerto Rico
Ponce School of Medicine - Practice Group
Ponce, PR, Puerto Rico
Puerto Rico Clinical and Translational Research Consortium
Rio Piedras, PR, Puerto Rico
Border Diabetic Centre
East London, Eastern Cape, South Africa
MediSynergy
Port Elizabeth, Eastern Cape, South Africa
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University of Witwatersrand-Clinical HIV Research Unit (CHRU)
Johannesburg, Gauteng, South Africa
Synexus SA Stanza Bopape Clinical Research Centre
Pretoria, Gauteng, South Africa
Pretoria West Hospital
Pretoria West, Gauteng, South Africa
Chris Hani Baragwanath Hospital, The Palliative Care Centre
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Cape Town, Western Cape, South Africa
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Be Part Yoluntu Centre
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Paarl Research Center
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Clinical Research Unit, University of Pretoria
Pretoria, , South Africa
Department of Neurology
Tygerberg, , South Africa
South East Asia Research Collaboration with Hawaii
Bangkok, , Thailand
Neurology unit, Department of Medicine,
Bangkok, , Thailand
Countries
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References
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Simpson DM, Rice AS, Emir B, Landen J, Semel D, Chew ML, Sporn J. A randomized, double-blind, placebo-controlled trial and open-label extension study to evaluate the efficacy and safety of pregabalin in the treatment of neuropathic pain associated with human immunodeficiency virus neuropathy. Pain. 2014 Oct;155(10):1943-54. doi: 10.1016/j.pain.2014.05.027. Epub 2014 Jun 4.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081244
Identifier Type: -
Identifier Source: org_study_id
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