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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Osteoporosis Medical Center
Beverly Hills, California, 90211 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia, Painful Diabetic Peripheral Neuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Age

- 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.

NCT01280747
Pfizer
Terminated
Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study

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Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study
Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
There are six practice types that are expected to be able to provide patients to this study. Of these, four (internal medicine, family/general practitioners, neurologists, and anesthesia/pain physicians) will be expected to enroll patients into both pDPN and FM disease groups. The fifth group, rheumatology physicians, will be expected to enroll patients into the FM cohort only and the sixth group, endocrinologists, will be expected to enroll patients into the pDPN cohort only.
  • Fibromyalgia
  • Painful Diabetic Peripheral Neuropathy
  • 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
  • 1
    Eligible fibromyalgia patients receive usual care with pregabalin prior authorization requirements in place
    Intervention: Other: prior authorization
  • 2
    Eligible fibromyalgia patients receive usual care without pregabalin prior authorization requirements in place
    Intervention: Other: no prior authorization
  • 3
    Eligible painful diabetic peripheral neuropathy patients receive usual care with pregabalin prior authorization requirements in place
    Intervention: Other: prior authorization
  • 4
    Eligible painful diabetic peripheral neuropathy patients receive usual care without pregabalin prior authorization requirements in place
    Intervention: Other: no prior authorization
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
42
April 2012
April 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01280747
A0081247
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

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