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

Last updated on October 14, 2019

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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.
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- 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.
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- 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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Descriptive Information
Brief TitleExamination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study
Official TitleExamination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study
Brief SummaryThe 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 DescriptionThis 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.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThere 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.
Condition
  • Fibromyalgia
  • Painful Diabetic Peripheral Neuropathy
Intervention
  • 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
Study Groups/Cohorts
  • 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
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusTerminated
Actual Enrollment
 (submitted: June 6, 2012)
42
Original Estimated Enrollment
 (submitted: January 19, 2011)
2288
Actual Study Completion DateApril 2012
Actual Primary Completion DateApril 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01280747
Other Study ID NumbersA0081247
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2012

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