NCT01770964

Evaluation of the Impact of Training on Outcome Measures in Subjects With Painful Diabetic Neuropathy

Evaluation of the Impact of Subject and Staff Training on the Pregabalin vs. Placebo Difference in Subjects With Painful Diabetic Neuropathy (PDN)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Analgesic Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Painful Distal Symmetric Sensorimotor Polyneuropathy

Interventions

Type	Name	Description
DRUG	Pregabalin
DRUG	placebo
BEHAVIORAL	Training Type A
BEHAVIORAL	Training Type B

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-01-18
• Last updated: 2013-01-18

Locations

6 sites across 1 country: United States