Pregabalin Trial In HIV Neuropathic Pain
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01145417
First received: June 7, 2010
Last updated: May 7, 2013
Last verified: May 2013
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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 (Adult, Senior) |
| 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
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 Healthcare Medical Group | |
| Palm Springs, California, United States, 92262 | |
| Desert Medical Group, Inc., dba Desert Oasis Helathcare 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 | |
| Riesgo de Fractura S.A. | |
| Bogota D.C., Cundinamarca, Colombia | |
| Asistencia Cientifica de Alta Complejidad | |
| Bogota, Cundinamarca, Colombia, 0000 | |
| 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 | |
| Toga Laboratory | |
| Johannesburg, Gauteng, South Africa, 1610 | |
| Drs Essack and Mitha | |
| Johannesburg, Gauteng, South Africa, 2113 | |
| 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Pregabalin Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on September 29, 2016