Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study
NCT01280747
Last updated date
ABOUT THIS 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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
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
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 < 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.
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Fibromyalgia, Painful Diabetic Peripheral NeuropathyExamination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study
NCT01280747
- Beverly Hills, California
- Lomita, California
- Orange, California
- Santa Maria, California
- Tulare, California
- West Hills, California
- Atlanta, Georgia
- Augusta, Georgia
- Hiram, Georgia
- Stockbridge, Georgia
- Anderson, Indiana
- Chesterton, Indiana
- No Conway, New Hampshire
- Smithtown, New York
- Miamisburg, Ohio
- Piqua, Ohio
- Ettrick, Virginia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study | |||
| Official Title | Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study | |||
| Brief 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. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | 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. | |||
| Condition |
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| Intervention |
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| Study Groups/Cohorts |
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| 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 Status | Terminated | |||
| Actual Enrollment | 42 | |||
| Original Estimated Enrollment | 2288 | |||
| Actual Study Completion Date | April 2012 | |||
| Actual Primary Completion Date | April 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01280747 | |||
| Other Study ID Numbers | A0081247 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | June 2012 | |||