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

This study is currently Recruiting

October 2011 By Pfizer

First Recieved on January 19, 2011

Last Updated on October 21, 2011

Sponsor: Pfizer
Collaborators:
Information provided by: Pfizer
Identifier: NCT01280747

Purpose

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.

Study Type: Observational
Study Design: Observational Model: Cohort, Time Perspective: Prospective

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Investigators

  • Investigator: Pfizer CT.gov Call Center - Study Director - Pfizer

Locations

  • Endocrine Associates of Long Island, P.C.

    Smithtown, New York 11787 United States

Conditions related to this trial:

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