Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy
A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy
1 other identifier
interventional
167
1 country
30
Brief Summary
The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2004
Shorter than P25 for phase_4
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedJanuary 25, 2021
April 1, 2009
September 8, 2005
January 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Nerve conduction measurements; Pain scores from patient diaries
Secondary Outcomes (1)
Proportion of patients with at least a 50% reduction in pain scores; Short-Form McGill Pain Questionnaire; Sleep interference scores from patient diaries; Clinical Global Impression of Change; Patient Global Impression of Change
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients must not be in poor or unstable health.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
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
Lake Worth, Florida, 33462, 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, 33351-6637, 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, 08901, 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, 75214, 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
Related Publications (6)
Alexander J Jr, Edwards RA, Manca L, Grugni R, Bonfanti G, Emir B, Whalen E, Watt S, Brodsky M, Parsons B. Integrating Machine Learning With Microsimulation to Classify Hypothetical, Novel Patients for Predicting Pregabalin Treatment Response Based on Observational and Randomized Data in Patients With Painful Diabetic Peripheral Neuropathy. Pragmat Obs Res. 2019 Oct 31;10:67-76. doi: 10.2147/POR.S214412. eCollection 2019.
PMID: 31802967DERIVEDAlexander J Jr, Edwards RA, Brodsky M, Manca L, Grugni R, Savoldelli A, Bonfanti G, Emir B, Whalen E, Watt S, Parsons B. Using time series analysis approaches for improved prediction of pain outcomes in subgroups of patients with painful diabetic peripheral neuropathy. PLoS One. 2018 Dec 6;13(12):e0207120. doi: 10.1371/journal.pone.0207120. eCollection 2018.
PMID: 30521533DERIVEDEdwards RA, Bonfanti G, Grugni R, Manca L, Parsons B, Alexander J. Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Adv Ther. 2018 Oct;35(10):1585-1597. doi: 10.1007/s12325-018-0780-3. Epub 2018 Sep 11.
PMID: 30206821DERIVEDParsons B, Li C, Emir B, Vinik AI. The efficacy of pregabalin for treating pain associated with diabetic peripheral neuropathy in subjects with type 1 or type 2 diabetes mellitus. Curr Med Res Opin. 2018 Nov;34(11):2015-2022. doi: 10.1080/03007995.2018.1509304. Epub 2018 Sep 20.
PMID: 30084288DERIVEDMarkman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.
PMID: 27611736DERIVEDArezzo JC, Rosenstock J, Lamoreaux L, Pauer L. Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: a double-blind placebo-controlled trial. BMC Neurol. 2008 Sep 16;8:33. doi: 10.1186/1471-2377-8-33.
PMID: 18796160DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
September 1, 2004
Study Completion
October 1, 2005
Last Updated
January 25, 2021
Record last verified: 2009-04