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

Stopped early

Conditions studied: Fibromyalgia, Painful Diabetic Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT01280747

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

42

Starts

2011-01-01

Expected to finish

2012-04-01

Last updated by the study team

2021-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A physician-confirmed diagnosis of either pDPN or FM, but not both.
• Initiation of a medication for pDPN or FM is clinically indicated, either as monotherapy or in combination with other treatments, as determined by the treating physician, and agreed to by the patient.
• No prior pregabalin use or pregabalin PA requests.

You may not qualify if…

• Age < 18 years at time of study enrollment.
• Females or are partners of males currently pregnant/lactating or intending to become pregnant in the next 6 months
• Physician-confirmed diagnosis of both pDPN and FM.

Where it is running

• Osteoporosis Medical Center — Beverly Hills, California, United States
• Torrence Clinical Research — Lomita, California, United States
• Joo-Hyung Lee, MD — Orange, California, United States
• Thomas M Dawes Jr. MD — Santa Maria, California, United States
• Tulare Family Practice Medical Group — Tulare, California, United States
• Affiliates of Medical Specialties — West Hills, California, United States
• Primary Care Specialists LLC — Atlanta, Georgia, United States
• Southern Family Medical Center, PC — Augusta, Georgia, United States
• WeCareMD, P.C. — Hiram, Georgia, United States
• Pain Care LLC — Stockbridge, Georgia, United States
• Broadway Family Medicine — Anderson, Indiana, United States
• Duneland Health and Wellness Institute — Chesterton, Indiana, United States
• Alan S. Goldenhar, DPM — No Conway, New Hampshire, United States
• Endocrine Associates of Long Island, P.C. — Smithtown, New York, United States
• Mound Family Practice — Miamisburg, Ohio, United States
• Piqua Family Practice — Piqua, Ohio, United States
• Ettrick Health Center — Ettrick, Virginia, United States

Full record on ClinicalTrials.gov

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