Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy

NCT00232141 | Completed Phase 3 Results

• 1 other identifier: A0081066
• Study Type: interventional
• Target: 302
• Locations: 2 countries
• Sites: 44

Brief Summary

Study to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy.

Conditions

HIV Infections; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline

  Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain).

  Baseline, Week 14

Secondary Outcomes (28)

• Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices

  Baseline, Week 14

• Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales

  Baseline, Week 14

• Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores

  Baseline, Week 14

• Change From Baseline for NRS-Sleep Interference Scores

  Baseline, Week 14

• Categorized Patient Global Impression of Change (PGIC)

  Baseline, Week 14

Other Outcomes (4)

• Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward)

  Baseline, Weeks 1 - 14 and Endpoint-BOCF

• Responders- Decreases of at Least 50% in Mean Weekly Pain Score

  Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward)

• Responders - Decreases of at Least 30% in Mean Weekly Pain Score

  Weeks 1-14 endpoint BOCF

Study Arms (2)

1

EXPERIMENTAL

Drug: pregabalin

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

pregabalin DRUG

75mg BID (can be titrated up to 150mg BID on day 4 based on individual response and up to 300mg BID at the end of week 1, visit 3 and end of week 2, visit 4)

1

Placebo DRUG

Placebo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with confirmed diagnosis of HIV infection
• HIV-associated neuropathic pain (nerve pain) for at least 3 months prior to study start
• subjects with moderate to severe pain
• subjects on stable HIV and pain medications (some medications are not allowed to be taken while participating in the study).

You may not qualify if:

• Pregnant or breast feeding females
• subjects using street drugs or alcohol abusers during the study
• subject's on anti-diabetic medications
• use of neuroregenerative agents or neurotoxic chemotherapeutic agents 3 months prior to study start and throughout the study
• use of neurotoxic drugs (other than D-drugs) within a month prior to study start and throughout the study.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (44)

Pfizer Investigational Site

Birmingham, Alabama, 35294, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85023, United States

Location

Pfizer Investigational Site

Little Rock, Arkansas, 72207, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90025, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90028, United States

Location

Pfizer Investigational Site

Sacramento, California, 95817-1460, United States

Location

Pfizer Investigational Site

San Diego, California, 92103, United States

Location

Pfizer Investigational Site

San Francisco, California, 94117, United States

Location

Pfizer Investigational Site

Stanford, California, 94301, United States

Location

Pfizer Investigational Site

West Hollywood, California, 90069, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80262, United States

Location

Pfizer Investigational Site

Miami, Florida, 33133, United States

Location

Pfizer Investigational Site

Pensacola, Florida, 32504-5719, United States

Location

Pfizer Investigational Site

Safety Harbor, Florida, 34695, United States

Location

Pfizer Investigational Site

Vero Beach, Florida, 32960, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, 33407, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30309, United States

Location

Pfizer Investigational Site

Honolulu, Hawaii, 96816, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60611, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60612, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21287-7609, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

Location

Pfizer Investigational Site

Springfield, Massachusetts, 01107, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110-1010, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

New York, New York, 10018, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Pfizer Investigational Site

New York, New York, 10029, United States

Location

Pfizer Investigational Site

Rochester, New York, 14642, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97209, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Pfizer Investigational Site

Austin, Texas, 78705, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75204, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75208-4234, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75208, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75219, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75390-9036, United States

Location

Pfizer Investigational Site

Longview, Texas, 75605, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98104, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53226, United States

Location

Pfizer Investigational Site

Ponce, 00716, Puerto Rico

Location

Pfizer Investigational Site

San Juan, 00909-1711, Puerto Rico

Location

Pfizer Investigational Site

San Juan, 00936-0000, Puerto Rico

Location

Related Links

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

MeSH Terms

Conditions

HIV Infections; Peripheral Nervous System Diseases

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: October 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: February 9, 2021
• Results First Posted: August 11, 2009

Record last verified: 2009-06

Locations

PR (3); US (41)