NCT00156078CompletedPhase 4
A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN).
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.35 sites in 19 countries450 target enrollmentStarted: January 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 450
- Locations
- 35
- Primary Endpoint
- Mean pain score
Study Overview
Brief Summary
A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Type 1 or 2 diabetes mellitus.
- •Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.
Exclusion Criteria
- •Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
- •Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.
Outcomes
Primary Outcomes
Mean pain score
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (35)
Loading locations...
Similar Trials
Completed
Phase 3
A Study of the Efficacy and Safety of Pregabalin for the Treatment of FibromyalgiaFibromyalgiaNCT00645398Pfizer's Upjohn has merged with Mylan to form Viatris Inc.751
Completed
Phase 3
A Study For Pregabalin In Patients With FibromyalgiaFibromyalgiaNCT01387607Pfizer's Upjohn has merged with Mylan to form Viatris Inc.343
Completed
Phase 3
A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.Generalized Tonic Clonic SeizuresNCT01747915Pfizer's Upjohn has merged with Mylan to form Viatris Inc.219
Completed
Phase 3
A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic PainNeuropathic PainNCT00301223Pfizer's Upjohn has merged with Mylan to form Viatris Inc.309
Completed
Phase 3
A Controlled Pregabalin Trial In FibromyalgiaFibromyalgiaNCT00230776Pfizer's Upjohn has merged with Mylan to form Viatris Inc.740