Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study
- Conditions
- FibromyalgiaPainful Diabetic Peripheral Neuropathy
- Interventions
- Other: no prior authorizationOther: prior authorization
- Registration Number
- NCT01280747
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 42
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 2 no prior authorization Eligible fibromyalgia patients receive usual care without pregabalin prior authorization requirements in place 4 no prior authorization Eligible painful diabetic peripheral neuropathy patients receive usual care without pregabalin prior authorization requirements in place 1 prior authorization Eligible fibromyalgia patients receive usual care with pregabalin prior authorization requirements in place 3 prior authorization Eligible painful diabetic peripheral neuropathy patients receive usual care with pregabalin prior authorization requirements in place
- Primary Outcome Measures
Name Time Method Evaluate the within-group differences (baseline to 6 mo.) in pain alleviation (using the 11 point numerical rating scale) in patients with pDPN and FM in real-world settings with a PA versus no PA policy in place restricting access to 6 months Quantify the between-group difference (baseline to 6 mo.) in direct all-cause medical costs for patients with pDPN and FM in real-world treatment settings with a prior authorization (PA) versus no PA policy in place restricting access to 6 months pregabalin 6 months pregabalin. 6 months
- Secondary Outcome Measures
Name Time Method Describe how pharmacologic treatment patterns for pDPN or FM differ between groups with PA and without PA in patients being treated in a naturalistic outpatient care setting, and who are followed for 6 mo. 6 months Describe non-pharmacologic treatment patterns in pDPN and FM patients in groups with PA versus no PA while being treated in a naturalistic outpatient care setting, and who are followed for 6 mo. 6 months Subset of patients who have at least 6 mo. pre-study time in the HIRD (HealthCore Integrated Research DatabaseSM) a within-group costs analysis (all cause) comparing pre-study healthcare utilization costs for the 6 mo. pre-baseline with on-study 6 months Compare the within-group differences (baseline to 6 mo.) in pain alleviation (using the NRS-11 scale) between groups (PA versus no PA), by condition (pDPN or FM). 6 months healthcare utilization costs (baseline to 6 mo.). 6 months Assess changes (baseline through 6 mo.) in other PRO measures in pDPN and FM patients subject to PA requirements for pregabalin versus those with no PA. 6 months
Trial Locations
- Locations (17)
Torrence Clinical Research
🇺🇸Lomita, California, United States
Primary Care Specialists LLC
🇺🇸Atlanta, Georgia, United States
Southern Family Medical Center, PC
🇺🇸Augusta, Georgia, United States
Thomas M Dawes Jr. MD
🇺🇸Santa Maria, California, United States
WeCareMD, P.C.
🇺🇸Hiram, Georgia, United States
Pain Care LLC
🇺🇸Stockbridge, Georgia, United States
Tulare Family Practice Medical Group
🇺🇸Tulare, California, United States
Alan S. Goldenhar, DPM
🇺🇸No Conway, New Hampshire, United States
Affiliates of Medical Specialties
🇺🇸West Hills, California, United States
Osteoporosis Medical Center
🇺🇸Beverly Hills, California, United States
Endocrine Associates of Long Island, P.C.
🇺🇸Smithtown, New York, United States
Ettrick Health Center
🇺🇸Ettrick, Virginia, United States
Joo-Hyung Lee, MD
🇺🇸Orange, California, United States
Broadway Family Medicine
🇺🇸Anderson, Indiana, United States
Duneland Health and Wellness Institute
🇺🇸Chesterton, Indiana, United States
Mound Family Practice
🇺🇸Miamisburg, Ohio, United States
Piqua Family Practice
🇺🇸Piqua, Ohio, United States