CClinicalTrials.gg
CompletedNCT00159731Updated Jan 22, 2021

Safety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

A Phase 4 interventional study of Pregabalin in Diabetic Peripheral Neuropathy, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 29 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to 1) provide continued pregabalin treatment for 6 additional months to patients who have taken part in the placebo controlled study A0081060; and 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day)

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Conditions studied

  • Diabetic Peripheral Neuropathy
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In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 160 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults with Type 1 or 2 diabetes
  • Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months

Exclusion criteria

Exclusion Criteria:

  • Patients must not be in poor or unstable health.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
160 participants

Interventions

  • DrugPregabalin
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What researchers measure

Primary outcomes

  1. Adverse events

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Study locations

29 sites
  • Pfizer Investigational Site
    Hot Springs, Arkansas 71913, United States
  • Pfizer Investigational Site
    La Jolla, California 92037, United States
  • Pfizer Investigational Site
    Torrance, California 90502, United States
  • Pfizer Investigational Site
    Torrance, California 90509, United States
  • Pfizer Investigational Site
    Denver, Colorado 80218, United States
  • Pfizer Investigational Site
    Ocala, Florida 34471, United States
  • Pfizer Investigational Site
    Ocala, Florida 34474, United States
  • Pfizer Investigational Site
    Palm Beach Gardens, Florida 33410, United States
  • Pfizer Investigational Site
    Sunrise, Florida 33351, United States
  • Pfizer Investigational Site
    West Palm Beach, Florida 33401, United States
  • Pfizer Investigational Site
    West Palm Beach, Florida 33407, United States
  • Pfizer Investigational Site
    Boston, Massachusetts 02115, United States
  • Pfizer Investigational Site
    Omaha, Nebraska 68116, United States
  • Pfizer Investigational Site
    Omaha, Nebraska 68131, United States
  • Pfizer Investigational Site
    Las Vegas, Nevada 89102, United States
  • Pfizer Investigational Site
    Englewood, New Jersey 07631, United States
  • Pfizer Investigational Site
    New Brunswick, New Jersey 08903, United States
  • Pfizer Investigational Site
    Albany, New York 12205, United States
  • Pfizer Investigational Site
    Rochester, New York 14618, United States
  • Pfizer Investigational Site
    Rochester, New York 14642, United States
  • Pfizer Investigational Site
    Greenville, North Carolina 27834, United States
  • Pfizer Investigational Site
    Toledo, Ohio 43623, United States
  • Pfizer Investigational Site
    Duncansville, Pennsylvania 16635, United States
  • Pfizer Investigational Site
    Dallas, Texas 75230, United States
  • Pfizer Investigational Site
    Dallas, Texas 75246, United States
  • Pfizer Investigational Site
    Houston, Texas 77030, United States
  • Pfizer Investigational Site
    San Antonio, Texas 78229, United States
  • Pfizer Investigational Site
    Salt Lake City, Utah 84108, United States
  • Pfizer Investigational Site
    Salt Lake City, Utah 84132, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00159731
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party
Sponsor
First posted
Sep 12, 2005
Start date
Jan 2005
Completion
May 2006
Last update
Jan 22, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.

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