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See termination reason in detailed description.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Eligible fibromyalgia patients receive usual care with pregabalin prior authorization requirements in place |
| |
| 2 | Eligible fibromyalgia patients receive usual care without pregabalin prior authorization requirements in place |
| |
| 3 | Eligible painful diabetic peripheral neuropathy patients receive usual care with pregabalin prior authorization requirements in place |
| |
| 4 | Eligible painful diabetic peripheral neuropathy patients receive usual care without pregabalin prior authorization requirements in place |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prior authorization | Other | This is a naturalistic study. The physician will prescribe medication(s) as appropriate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 | |
| pregabalin. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osteoporosis Medical Center | Beverly Hills | California | 90211 | United States | ||
| Torrence Clinical Research |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| no prior authorization | Other | This is a naturalistic study. The physician will prescribe medication(s) as appropriate |
|
| prior authorization | Other | This is a naturalistic study. The physician will prescribe medication(s) as appropriate |
|
| no prior authorization | Other | This is a naturalistic study. The physician will prescribe medication(s) as appropriate |
|
| 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 |
| 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 |
| 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 |
| Lomita |
| California |
| 90717 |
| United States |
| Joo-Hyung Lee, MD | Orange | California | 92868 | United States |
| Thomas M Dawes Jr. MD | Santa Maria | California | 93455 | United States |
| Tulare Family Practice Medical Group | Tulare | California | 93274 | United States |
| Affiliates of Medical Specialties | West Hills | California | 91307 | United States |
| Primary Care Specialists LLC | Atlanta | Georgia | 30312 | United States |
| Southern Family Medical Center, PC | Augusta | Georgia | 30906 | United States |
| WeCareMD, P.C. | Hiram | Georgia | 30141 | United States |
| Pain Care LLC | Stockbridge | Georgia | 30281 | United States |
| Broadway Family Medicine | Anderson | Indiana | 46012 | United States |
| Duneland Health and Wellness Institute | Chesterton | Indiana | 46304 | United States |
| Alan S. Goldenhar, DPM | No Conway | New Hampshire | 03860 | United States |
| Endocrine Associates of Long Island, P.C. | Smithtown | New York | 11787 | United States |
| Mound Family Practice | Miamisburg | Ohio | 45342 | United States |
| Piqua Family Practice | Piqua | Ohio | 45356 | United States |
| Ettrick Health Center | Ettrick | Virginia | 23803 | United States |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078482 | Prior Authorization |
| ID | Term |
|---|---|
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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