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Training Type A, pregabalin for Diabetes
Phase 4
Waitlist Available
Led By Jeremiah J Trudeau, PhD
Research Sponsored by Analgesic Solutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening/visit 1 (day 1) and visit 4 (day 15-18)
Awards & highlights
Study Summary
The difference between active treatment and placebo in a clinical trial of an analgesic appears to depend on a variety of factors other than the actual efficacy of the drug itself, including various aspects of study design and conduct. One potential such factor is how information about the study is presented to research staff and patients. The purpose of this study is to examine the impact of different presentations of information on the difference between pregabalin and placebo observed in a clinical trial in patients with painful diabetic neuropathy.
Eligible Conditions
- Diabetes
- Peripheral Neuropathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening/visit 1 (day 1) and visit 4 (day 15-18)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening/visit 1 (day 1) and visit 4 (day 15-18)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change in pain severity rating
Trial Design
4Treatment groups
Experimental Treatment
Group I: Training Type B, pregabalinExperimental Treatment2 Interventions
Subjects randomized to receive pregabalin at a site that received training Type B
Group II: Training Type B, placeboExperimental Treatment2 Interventions
Subjects randomized to receive placebo at a site that received training Type B
Group III: Training Type A, pregabalinExperimental Treatment2 Interventions
Subjects randomized to receive pregabalin at a site that received training Type A
Group IV: Training Type A, placeboExperimental Treatment2 Interventions
Subjects randomized to receive placebo at a site that received training Type A
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pregabalin
FDA approved
placebo
2010
Completed Phase 4
~6580
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Who is running the clinical trial?
PfizerIndustry Sponsor
4,571 Previous Clinical Trials
10,923,199 Total Patients Enrolled
12 Trials studying Diabetes
107,251 Patients Enrolled for Diabetes
Analgesic SolutionsLead Sponsor
8 Previous Clinical Trials
413 Total Patients Enrolled
Astellas Pharma Europe B.V.Industry Sponsor
107 Previous Clinical Trials
71,139 Total Patients Enrolled
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