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Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01049217
First received: January 13, 2010
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.


Condition Intervention Phase
Neuropathy
 Drug: pregabalin
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial Of Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081244)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Endpoint mean pain score derived from subject's diary for daily average pain on an 11 point pain numeric rating scale (NRS-Average) [ Time Frame: Daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Global Impression of Change (PGIC) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Neurological examination [ Time Frame: First Visit ] [ Designated as safety issue: Yes ]
  • Mini-International Neuropsychiatric Interview (MINI) Modules (depression, mania, substance abuse/dependence, and psychosis modules) • Sheehan-Suicidality Tracking Scale (SSTS); • Patient Health Questionnaire-8 [ Time Frame: First Visit ] [ Designated as safety issue: Yes ]
  • (PHQ-8); • Diagnostic Neuropathy Worksheet [ Time Frame: First Visit ] [ Designated as safety issue: Yes ]
  • Clinician Global Impression of Change (CGIC) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Daily NRS Sleep Interference (NRS-Sleep) [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Daily NRS Current Pain (NRS Current ) [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Brief Pain Inventory-Short Form (BPI-sf) [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Week 1 and Week 16 ] [ Designated as safety issue: No ]
  • Actigraphy Functional/Sleep Assessment [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Medical Outcomes Survey (MOS)-Sleep Scale [ Time Frame: Week 1 and Week 16 ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Week 1 and Week 16 ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: Week 1 and Week 16 ] [ Designated as safety issue: No ]
  • Adverse Event monitoring throughout the trial [ Time Frame: At all visits through Week 17 ] [ Designated as safety issue: Yes ]
  • Laboratory testing including hematology, chemistry, CD4 count and CD8 count, HIV plasma viral load, B12, VDRL, toxic screens drugs for drugs and alcohol, reflex TSH, urinalysis [ Time Frame: First visit and Week 17 ] [ Designated as safety issue: Yes ]
  • Serum pregnancy testing at screening urine pregnancy test (and as clinically indicated during study) [ Time Frame: First visit and Week 1 ] [ Designated as safety issue: Yes ]
  • Physical Examination and vital signs [ Time Frame: Week 1, Week 8, and Week 17 ] [ Designated as safety issue: Yes ]

Enrollment: 391
Study Start Date: April 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active drug Drug: pregabalin
Pregabalin 75 mg-300mg twice daily during the course of the study.
Placebo Comparator: Control Drug: placebo
Subjects may be assigned to placebo during this study. The study duration is approximately 19 weeks.

Detailed Description:

Based on DMC interim efficacy analysis results indicating a low probability for success the study was terminated 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:

  • Men and women, ages of 18 or greater
  • Documented evidence of HIV-1 infection
  • Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with subjective sensory symptom of pain
  • Pain starts in the feet

Exclusion Criteria:

  • Subject has untreated vitamin B12 deficiency (serum B12 level <200 pg/ml) or if treated B12 deficiency -treatment is less than 6 months of B12 supplementation (injection or intranasal B12) prior to screening
  • Diabetes mellitus requiring regular medical treatment (other than diet and exercise) or HbA1C >6.9
  • Subjects with peripheral neuropathic pain that is not associated with HIV infection; including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy, radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related to: metabolic abnormalities; nutritional factors; vascular insults; inflammation; autoimmune disease; and malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049217

  Show 63 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01049217     History of Changes
Other Study ID Numbers: A0081244
Study First Received: January 13, 2010
Last Updated: June 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
neuropathy
pain
HIV-1
HIV Infections

Additional relevant MeSH terms:
Neuralgia
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Pain
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
 Poisoning
Substance-Related Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 22, 2013