Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01049217
First received: January 13, 2010
Last updated: June 25, 2012
Last verified: June 2012
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Purpose
The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuropathy |
Drug: pregabalin Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial Of Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081244) |
Resource links provided by NLM:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Pregabalin
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Endpoint mean pain score derived from subject's diary for daily average pain on an 11 point pain numeric rating scale (NRS-Average) [ Time Frame: Daily ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patient Global Impression of Change (PGIC) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- Neurological examination [ Time Frame: First Visit ] [ Designated as safety issue: Yes ]
- Mini-International Neuropsychiatric Interview (MINI) Modules (depression, mania, substance abuse/dependence, and psychosis modules) • Sheehan-Suicidality Tracking Scale (SSTS); • Patient Health Questionnaire-8 [ Time Frame: First Visit ] [ Designated as safety issue: Yes ]
- (PHQ-8); • Diagnostic Neuropathy Worksheet [ Time Frame: First Visit ] [ Designated as safety issue: Yes ]
- Clinician Global Impression of Change (CGIC) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- Daily NRS Sleep Interference (NRS-Sleep) [ Time Frame: Daily ] [ Designated as safety issue: No ]
- Daily NRS Current Pain (NRS Current ) [ Time Frame: Daily ] [ Designated as safety issue: No ]
- Brief Pain Inventory-Short Form (BPI-sf) [ Time Frame: Monthly ] [ Designated as safety issue: No ]
- Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Week 1 and Week 16 ] [ Designated as safety issue: No ]
- Actigraphy Functional/Sleep Assessment [ Time Frame: Daily ] [ Designated as safety issue: No ]
- Medical Outcomes Survey (MOS)-Sleep Scale [ Time Frame: Week 1 and Week 16 ] [ Designated as safety issue: No ]
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Week 1 and Week 16 ] [ Designated as safety issue: No ]
- SF-36 [ Time Frame: Week 1 and Week 16 ] [ Designated as safety issue: No ]
- Adverse Event monitoring throughout the trial [ Time Frame: At all visits through Week 17 ] [ Designated as safety issue: Yes ]
- Laboratory testing including hematology, chemistry, CD4 count and CD8 count, HIV plasma viral load, B12, VDRL, toxic screens drugs for drugs and alcohol, reflex TSH, urinalysis [ Time Frame: First visit and Week 17 ] [ Designated as safety issue: Yes ]
- Serum pregnancy testing at screening urine pregnancy test (and as clinically indicated during study) [ Time Frame: First visit and Week 1 ] [ Designated as safety issue: Yes ]
- Physical Examination and vital signs [ Time Frame: Week 1, Week 8, and Week 17 ] [ Designated as safety issue: Yes ]
| Enrollment: | 391 |
| Study Start Date: | April 2010 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Active drug |
Drug: pregabalin
Pregabalin 75 mg-300mg twice daily during the course of the study.
|
| Placebo Comparator: Control |
Drug: placebo
Subjects may be assigned to placebo during this study. The study duration is approximately 19 weeks.
|
Detailed Description:
Based on DMC interim efficacy analysis results indicating a low probability for success the study was terminated on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women, ages of 18 or greater
- 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:
- Subject has untreated vitamin B12 deficiency (serum B12 level <200 pg/ml) or if treated B12 deficiency -treatment is less than 6 months of B12 supplementation (injection or intranasal B12) prior to screening
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049217
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Hide Study LocationsLocations
| United States, Arizona | |
| Southwest Center for HIV/AIDS | |
| Phoenix, Arizona, United States, 85006 | |
| SW Center for HIV/AIDS | |
| Phoenix, Arizona, United States, 85006 | |
| Arizona Research Center | |
| Phoenix, Arizona, United States, 85023 | |
| United States, California | |
| Anthony Mills, MD, Inc. | |
| Los Angeles, California, United States, 90069 | |
| David Geffen School of Medicine at UCLA c/o NNAB | |
| Los Angeles, California, United States, 90095 | |
| AIDS Research Alliance of America | |
| Los Angeles, California, United States, 90015 | |
| Providence Clinical Research | |
| North Hollywood, California, United States, 91606 | |
| Desert Medical Group, Inc. dba Desert Oasis Healthcare Medical Group | |
| Palm Springs, California, United States, 92262 | |
| University of California San Diego | |
| San Diego, California, United States, 92103 | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| United States, Florida | |
| Neuroscience Consultants, LLC. | |
| Aventura, Florida, United States, 33180 | |
| South Florida Medical Research | |
| Aventura, Florida, United States, 33180 | |
| The Kinder Medical Group | |
| Miami, Florida, United States, 33133 | |
| Wohlfeiler, Piperato & Associates, LLC | |
| Miami Beach, Florida, United States, 33139 | |
| Meridien Research | |
| Tampa, Florida, United States, 33606 | |
| United States, Georgia | |
| Midtown Neurology, PC | |
| Atlanta, Georgia, United States, 30312 | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| Neurology Specialists of Decatur Research Center | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Rehabilitation Institute of Chicago | |
| Chicago, Illinois, United States, 60611 | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| United States, Ohio | |
| University of Toledo Medical Center | |
| Toledo, Ohio, United States, 43614 | |
| University of Toledo | |
| Toledo, Ohio, United States, 43614 | |
| United States, Texas | |
| University of Texas Physicians | |
| Bellaire, Texas, United States, 77401 | |
| Amelia Court HIV Research Clinic | |
| Dallas, Texas, United States, 75235 | |
| The University of Texas Medical School at Houston | |
| Houston, Texas, United States, 77030 | |
| Colombia | |
| Asistencia Cientifica de Alta Complejidad | |
| Bogota, Cundinamarca, Colombia, 0000 | |
| Centro Instituto de Investigaciones Fundación Universitaria Sanitas | |
| Bogota, Cundinamarca, Colombia | |
| Riesgo de Fractura S.A | |
| Bogotá, Cundinamarca, Colombia, 0000 | |
| Instituto Colombiano para el Avance de la Medicina- Santander S.A.S. - ICAMEDIC Santander S.A.S | |
| Bucaramanga, Santander, Colombia, 0000 | |
| Dominican Republic | |
| Instituto Dominicano de Estudios Virológicos - IDEV | |
| Santo Domingo, Dominican Republic | |
| India | |
| Surakshaka Multispeciality Hospital | |
| Hyderabad, Andhra Pradesh, India, 500 072 | |
| Mahavir Hospital and Research Centre | |
| Hyderabad, Andhra Pradesh, India, 500 004 | |
| Infectious Disease Clinic | |
| Ahmedabad, Gujarat, India, 380 009 | |
| Jaslok Hospital & Research Centre | |
| Mumbai, Maharashtra, India, 400026 | |
| Deenanath Mangeshkar Hospital and Research Centre | |
| Pune, Maharashtra, India, 411 004 | |
| YR Gaitonde Centre for AIDS Research and Education | |
| Chennai, Tamil Nadu, India, 600 113 | |
| Peru | |
| Hospital Nacional Guillermo Almenara Irigoyen | |
| Lima, Peru, L 13 | |
| Hospital Nacional Dos de Mayo | |
| Lima, Peru, L 01 | |
| Poland | |
| Katedra Chorob Zakaznych i Hepatologii UMK w Toruniu CM w Bydgoszczy | |
| Bydgoszcz, Poland, 85-030 | |
| Oddzial Diagnostyki i Terapii AIDS | |
| Chorzow, Poland, 41-500 | |
| Puerto Rico | |
| Ponce School of Medicine-CAIMED Center | |
| Ponce, Puerto Rico, 00716 | |
| Ponce School of Medicine - Practice Group | |
| Ponce, Puerto Rico, 00732-7004 | |
| Puerto Rico Clinical and Translational Research Consortium | |
| Rio Piedras, Puerto Rico, 00935 | |
| South Africa | |
| Border Diabetic Centre | |
| East London, Eastern Cape, South Africa, 5200 | |
| MediSynergy | |
| Port Elizabeth, Eastern Cape, South Africa, 6065 | |
| Worthwhile Clinical Trials | |
| Benoni, Gauteng, South Africa, 1500 | |
| University of Witwatersrand-Clinical HIV Research Unit (CHRU) | |
| Johannesburg, Gauteng, South Africa, 2193 | |
| Toga Laboratory | |
| Johannesburg, Gauteng, South Africa, 1610 | |
| Drs Essack and Mitha | |
| Johannesburg, Gauteng, South Africa, 2113 | |
| Synexus SA Stanza Bopape Clinical Research Centre | |
| Pretoria, Gauteng, South Africa, 0122 | |
| Pretoria West Hospital | |
| Pretoria West, Gauteng, South Africa, 0117 | |
| Chris Hani Baragwanath Hospital, The Palliative Care Centre | |
| Soweto, Gauteng, South Africa, 1808 | |
| Dr J. Reddy's Surgery | |
| Stanger, KwaZulu Natal, South Africa, 4450 | |
| University of Cape Town | |
| Cape Town, Western Cape, South Africa, 7925 | |
| Synapta Clinical Research Centre | |
| Durban, South Africa, 4001 | |
| Innovir Institute | |
| Gauteng, South Africa, 2047 | |
| Mzansi Ethical Research Centre | |
| Middelburg, South Africa, 1050 | |
| Be Part Yoluntu Centre | |
| Paarl, South Africa, 7626 | |
| Paarl Research Center | |
| Paarl, South Africa, 7646 | |
| Clinical Research Unit, University of Pretoria | |
| Pretoria, South Africa, 0002 | |
| Department of Neurology | |
| Tygerberg, South Africa, 7505 | |
| Thailand | |
| South East Asia Research Collaboration with Hawaii | |
| Bangkok, Thailand, 10330 | |
| Neurology unit, Department of Medicine, | |
| Bangkok, Thailand, 10400 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01049217 History of Changes |
| Other Study ID Numbers: | A0081244 |
| Study First Received: | January 13, 2010 |
| Last Updated: | June 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
neuropathy pain HIV-1 HIV Infections |
Additional relevant MeSH terms:
|
Neuralgia Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Pain Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms |
Poisoning Substance-Related Disorders Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on June 17, 2013