Pregabalin Trial In HIV Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

An Open-Label, Extension Safety Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081251)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01145417
• Other study ID #: A0081251
• Status: Terminated
• Phase: Phase 3
• Start date: July 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 217
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1 Infection
• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• pregabalin (Lyrica)
150 mg-600 mg/day (twice daily)

Locations

Country	Name	City	State
Colombia	Asistencia Cientifica de Alta Complejidad	Bogota	Cundinamarca
Colombia	Riesgo de Fractura S.A.	Bogota D.C.	Cundinamarca
India	Infectious Disease Clinic	Ahemdabad	Gujarat
India	Surakshaka Multispeciality Hospital	Hyderabad	Andhra Pradesh
India	Deenanath Mangeshkar Hospital and Research Centre	Pune	Maharashtra
Peru	Hospital Nacional Dos de Mayo	Lima
Puerto Rico	RCMI-Clinical Research Center	Rio Piedras
South Africa	Worthwhile Clinical Trials (WWCT), Lake View Hospital	Benoni	Gauteng
South Africa	University of Cape Town	Cape Town	Western Cape
South Africa	Synapta Clinical Research Centre	Durban
South Africa	Drs Essack and Mitha	Johannesburg	Gauteng
South Africa	Toga Laboratory	Johannesburg	Gauteng
South Africa	Be Part Yoluntu Centre	Paarl
South Africa	Paarl Research Center	Paarl
South Africa	MediSynergy	Port Elizabeth	Eastern Cape
South Africa	Pretoria West Hospital	Pretoria West	Gauteng
South Africa	Dr J. Reddy's Surgery	Stanger	KwaZulu Natal
Thailand	Neurology unit, Department of Medicine,	Bangkok
Thailand	South East Asia Research Collaboration with Hawaii	Bangkok
United States	Neuroscience Consultants, LLC	Aventura	Florida
United States	South Florida Medical Research	Aventura	Florida
United States	Providence Clinical Research	Burbank	California
United States	Mount Sinai School of Medicine	New York	New York
United States	Desert Medical Group, Inc., dba Desert Oasis Healthcare Medical Group	Palm Springs	California
United States	Desert Medical Group, Inc., dba Desert Oasis Helathcare Medical Group	Palm Springs	California
United States	Arizona Research Center	Phoenix	Arizona
United States	Southwest Center for HIV/AIDS	Phoenix	Arizona
United States	University of California San Diego	San Diego	California
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Colombia,  India,  Peru,  Puerto Rico,  South Africa,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire	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.	Baseline, Week 24
Secondary	Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire	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.	Baseline, Week 24
Secondary	Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire	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).	Baseline, Week 24
Secondary	36-Item Short-Form Health Survey (SF-36)	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).	Baseline, Week 24
Secondary	Visual Analogue Scale for Pain (VAS-pain)	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.	Baseline, Week 4, 8, 12, 16, 20, 24
Secondary	Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)	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.	Week 24
Secondary	Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories	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.	Baseline up to Week 25
Secondary	Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)	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.	Baseline

External Links

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