Clinical trial NCT01145417: Pregabalin Trial In HIV Neuropathic Pain
Official title: An Open-Label, Extension Safety Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081251)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: HIV-1 Infection
Neuropathic Pain
Keywords: peripheral neuropathic pain
pregabalin
safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-16
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The parent double blind study was stopped at interim analysis due to lack of efficacy and therefore this open label extension study was also terminated simultaneously on April 2, 2012; the termination was unrelated to any safety findings that could impact patient health.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 30 days after last dose of study treatment
Secondary outcomes:
measure: Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
timeFrame: Baseline, Week 24
measure: Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
timeFrame: Baseline, Week 24
measure: Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire
timeFrame: Baseline, Week 24
measure: 36-Item Short-Form Health Survey (SF-36)
timeFrame: Baseline, Week 24
measure: Visual Analogue Scale for Pain (VAS-pain)
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24
measure: Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
timeFrame: Week 24
measure: Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories
timeFrame: Baseline up to Week 25
measure: Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Baseline
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Center for HIV/AIDS
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Palm Springs
country: United States
facility: Desert Medical Group, Inc., dba Desert Oasis Healthcare Medical Group
state: California
city: Palm Springs
country: United States
facility: Desert Medical Group, Inc., dba Desert Oasis Helathcare Medical Group
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aventura
country: United States
facility: Neuroscience Consultants, LLC
state: Florida
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Bogota D.C.
country: Colombia
facility: Riesgo de Fractura S.A.
state: Cundinamarca
city: Bogota
country: Colombia
facility: Asistencia Cientifica de Alta Complejidad
state: Cundinamarca
city: Hyderabad
country: India
facility: Surakshaka Multispeciality Hospital
state: Andhra Pradesh
city: Ahemdabad
country: India
facility: Infectious Disease Clinic
state: Gujarat
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
state: Maharashtra
city: Lima
country: Peru
facility: Hospital Nacional Dos de Mayo
city: Rio Piedras
country: Puerto Rico
facility: RCMI-Clinical Research Center
city: Port Elizabeth
country: South Africa
facility: MediSynergy
state: Eastern Cape
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials (WWCT), Lake View Hospital
state: Gauteng
city: Johannesburg
country: South Africa
facility: Toga Laboratory
state: Gauteng
city: Johannesburg
country: South Africa
facility: Drs Essack and Mitha
state: Gauteng
city: Pretoria West
country: South Africa
facility: Pretoria West Hospital
state: Gauteng
city: Stanger
country: South Africa
facility: Dr J. Reddy's Surgery
state: KwaZulu Natal
city: Cape Town
country: South Africa
facility: University of Cape Town
state: Western Cape
city: Durban
country: South Africa
facility: Synapta Clinical Research Centre
city: Paarl
country: South Africa
facility: Paarl Research Center
city: Paarl
country: South Africa
facility: Be Part Yoluntu Centre
city: Bangkok
country: Thailand
facility: South East Asia Research Collaboration with Hawaii
city: Bangkok
country: Thailand
facility: Neurology unit, Department of Medicine,
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.