Pregabalin Trial In HIV Neuropathic Pain

NCT01145417 | Terminated Phase 3 Results

• 1 other identifier: A0081251
• Study Type: interventional
• Target: 217
• Locations: 7 countries
• Sites: 29

Brief Summary

This study examines the safety of pregabalin over a 6 month period in patients with neuropathic pain associated with HIV infection as an extension of another trial that tests the efficacy of pregabalin.

Conditions

HIV-1 Infection; Neuropathic Pain

Keywords

peripheral neuropathic pain; pregabalin; safety

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

  Baseline up to 30 days after last dose of study treatment

Secondary Outcomes (8)

• Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire

  Baseline, Week 24

• Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire

  Baseline, Week 24

• Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire

  Baseline, Week 24

• 36-Item Short-Form Health Survey (SF-36)

  Baseline, Week 24

• Visual Analogue Scale for Pain (VAS-pain)

  Baseline, Week 4, 8, 12, 16, 20, 24

Study Arms (1)

Pregabalin (Lyrica)

EXPERIMENTAL

Drug: pregabalin (Lyrica)

Interventions

pregabalin (Lyrica) DRUG

150 mg-600 mg/day (twice daily)

Pregabalin (Lyrica)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who participated in the preceding A0081244 double-blind trial and completed at least through Visit 9 of that trial.
• Subjects with painful distal sensory polyneuropathy (DSP) interested in treatment based on investigator's clinical judgment.
• Subjects who had acceptable tolerability of study drug in A0081244.

You may not qualify if:

• Clinically significant or unstable conditions that, in the opinion of the investigator, would compromise participation in the study. This includes, for example, medical conditions such as, but not limited to: hepatic, renal, respiratory, hematological, immunological, cardiovascular diseases, arrhythmia, inflammatory or rheumatologic disease, active infections, symptomatic peripheral vascular disease, psychiatric illness, and untreated endocrine disorders.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• Active Acquired Immune Deficiency Syndrome (AIDS)- defining Opportunistic Infection (OI) that requires hospitalization.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (29)

Southwest Center for HIV/AIDS

Phoenix, Arizona, 85006, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Providence Clinical Research

Burbank, California, 91505, United States

Location

Desert Medical Group, Inc., dba Desert Oasis Healthcare Medical Group

Palm Springs, California, 92262, United States

Location

Desert Medical Group, Inc., dba Desert Oasis Helathcare Medical Group

Palm Springs, California, 92262, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Neuroscience Consultants, LLC

Aventura, Florida, 33180, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Riesgo de Fractura S.A.

Bogota D.C., Cundinamarca, Colombia

Location

Asistencia Cientifica de Alta Complejidad

Bogota, Cundinamarca, 0000, Colombia

Location

Surakshaka Multispeciality Hospital

Hyderabad, Andhra Pradesh, 500 072, India

Location

Infectious Disease Clinic

Ahemdabad, Gujarat, 380 009, India

Location

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashtra, 411 004, India

Location

Hospital Nacional Dos de Mayo

Lima, L 01, Peru

Location

RCMI-Clinical Research Center

Rio Piedras, 00935, Puerto Rico

Location

MediSynergy

Port Elizabeth, Eastern Cape, 6065, South Africa

Location

Worthwhile Clinical Trials (WWCT), Lake View Hospital

Benoni, Gauteng, 1500, South Africa

Location

Toga Laboratory

Johannesburg, Gauteng, 1610, South Africa

Location

Drs Essack and Mitha

Johannesburg, Gauteng, 2113, South Africa

Location

Pretoria West Hospital

Pretoria West, Gauteng, 0117, South Africa

Location

Dr J. Reddy's Surgery

KwaDukuza, KwaZulu-Natal, 4450, South Africa

Location

University of Cape Town

Cape Town, Western Cape, 7925, South Africa

Location

Synapta Clinical Research Centre

Durban, 4001, South Africa

Location

Paarl Research Center

Paarl, 7626, South Africa

Location

Be Part Yoluntu Centre

Paarl, 7646, South Africa

Location

South East Asia Research Collaboration with Hawaii

Bangkok, 10330, Thailand

Location

Neurology unit, Department of Medicine,

Bangkok, 10400, Thailand

Location

Related Publications (1)

• 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.

  PMID: 24907403 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Neuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The parent double blind trial A0081244 (NCT01049217) was stopped at interim analysis due to lack of efficacy and therefore this open label extension study was also terminated.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 16, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 28, 2021
• Results First Posted: June 27, 2013

Record last verified: 2013-05

Locations

CO (2); US (10); PE (1); PR (1); TH (2); ZA (10); IN (3)