Pregabalin Trial In HIV Neuropathic Pain

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01145417
First received: June 7, 2010
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
Neuropathic Pain
Drug: pregabalin (Lyrica)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Extension Safety Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081251)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 30 days after last dose of study treatment ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a Human Immunodeficiency Virus (HIV) neuropathy pain. Number of participants who responded "Yes/No" to Question 1: Are you currently employed (working for pay)? are reported.

  • Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days.

  • Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).

  • 36-Item Short-Form Health Survey (SF-36) [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).

  • Visual Analogue Scale for Pain (VAS-pain) [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: No ]
    Participants rated the severity of HIV neuropathy pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

  • Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    PGI-C: participant rated instrument to measure participant's change in overall status since the start of the study, on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.

  • Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories [ Time Frame: Baseline up to Week 25 ] [ Designated as safety issue: Yes ]
    S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.

  • Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated "Over past 2 weeks, how often bothered by any of following problems?": little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual(8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity.


Enrollment: 217
Study Start Date: July 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin (Lyrica) Drug: pregabalin (Lyrica)
150 mg-600 mg/day (twice daily)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145417

Locations
United States, Arizona
Southwest Center for HIV/AIDS
Phoenix, Arizona, United States, 85006
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
Providence Clinical Research
Burbank, California, United States, 91505
Desert Medical Group, Inc., dba Desert Oasis Helathcare Medical Group
Palm Springs, California, United States, 92262
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
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Colombia
Asistencia Cientifica de Alta Complejidad
Bogota, Cundinamarca, Colombia, 0000
Riesgo de Fractura S.A.
Bogota D.C., Cundinamarca, Colombia
India
Surakshaka Multispeciality Hospital
Hyderabad, Andhra Pradesh, India, 500 072
Infectious Disease Clinic
Ahemdabad, Gujarat, India, 380 009
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, India, 411 004
Peru
Hospital Nacional Dos de Mayo
Lima, Peru, L 01
Puerto Rico
RCMI-Clinical Research Center
Rio Piedras, Puerto Rico, 00935
South Africa
MediSynergy
Port Elizabeth, Eastern Cape, South Africa, 6065
Worthwhile Clinical Trials (WWCT), Lake View Hospital
Benoni, Gauteng, South Africa, 1500
Drs Essack and Mitha
Johannesburg, Gauteng, South Africa, 2113
Toga Laboratory
Johannesburg, Gauteng, South Africa, 1610
Pretoria West Hospital
Pretoria West, Gauteng, South Africa, 0117
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
Paarl Research Center
Paarl, South Africa, 7626
Be Part Yoluntu Centre
Paarl, South Africa, 7646
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: NCT01145417     History of Changes
Other Study ID Numbers: A0081251
Study First Received: June 7, 2010
Results First Received: May 7, 2013
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
peripheral neuropathic pain
pregabalin
safety

Additional relevant MeSH terms:
Neuralgia
HIV Infections
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 01, 2014