NCT01280747

Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that fibromyalgia (FM) and painful diabetic peripheral neuropathy (pDPN) patients with access restrictions on pregabalin will lead to higher healthcare resource use and cost compared to patients without such restrictions on pregabalin in a naturalistic setting. The randomization will occur at the physician level and not the patient level.

Detailed description

This trial was terminated prematurely on April 2, 2012, due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety or efficacy concerns.

Conditions

• Fibromyalgia
• Painful Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
OTHER	prior authorization	This is a naturalistic study. The physician will prescribe medication(s) as appropriate
OTHER	no prior authorization	This is a naturalistic study. The physician will prescribe medication(s) as appropriate
OTHER	prior authorization	This is a naturalistic study. The physician will prescribe medication(s) as appropriate
OTHER	no prior authorization	This is a naturalistic study. The physician will prescribe medication(s) as appropriate

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-01-21
• Last updated: 2021-01-26

Locations

17 sites across 1 country: United States