Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01280747
First received: January 19, 2011
Last updated: June 6, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia Painful Diabetic Peripheral Neuropathy |
Other: prior authorization Other: no prior authorization |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- pregabalin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- pregabalin. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- healthcare utilization costs (baseline to 6 mo.). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 42 |
| Study Start Date: | January 2011 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Eligible fibromyalgia patients receive usual care with pregabalin prior authorization requirements in place
|
Other: prior authorization
This is a naturalistic study. The physician will prescribe medication(s) as appropriate
|
|
2
Eligible fibromyalgia patients receive usual care without pregabalin prior authorization requirements in place
|
Other: no prior authorization
This is a naturalistic study. The physician will prescribe medication(s) as appropriate
|
|
3
Eligible painful diabetic peripheral neuropathy patients receive usual care with pregabalin prior authorization requirements in place
|
Other: prior authorization
This is a naturalistic study. The physician will prescribe medication(s) as appropriate
|
|
4
Eligible painful diabetic peripheral neuropathy patients receive usual care without pregabalin prior authorization requirements in place
|
Other: no prior authorization
This is a naturalistic study. The physician will prescribe medication(s) as appropriate
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280747
Locations
| United States, California | |
| Osteoporosis Medical Center | |
| Beverly Hills, California, United States, 90211 | |
| Torrence Clinical Research | |
| Lomita, California, United States, 90717 | |
| Joo-Hyung Lee, MD | |
| Orange, California, United States, 92868 | |
| Thomas M Dawes Jr. MD | |
| Santa Maria, California, United States, 93455 | |
| Tulare Family Practice Medical Group | |
| Tulare, California, United States, 93274 | |
| Affiliates of Medical Specialties | |
| West Hills, California, United States, 91307 | |
| United States, Georgia | |
| Primary Care Specialists LLC | |
| Atlanta, Georgia, United States, 30312 | |
| Southern Family Medical Center, PC | |
| Augusta, Georgia, United States, 30906 | |
| WeCareMD, P.C. | |
| Hiram, Georgia, United States, 30141 | |
| Pain Care LLC | |
| Stockbridge, Georgia, United States, 30281 | |
| United States, Indiana | |
| Broadway Family Medicine | |
| Anderson, Indiana, United States, 46012 | |
| Duneland Health and Wellness Institute | |
| Chesterton, Indiana, United States, 46304 | |
| United States, New Hampshire | |
| Alan S. Goldenhar, DPM | |
| No Conway, New Hampshire, United States, 03860 | |
| United States, New York | |
| Endocrine Associates of Long Island, P.C. | |
| Smithtown, New York, United States, 11787 | |
| United States, Ohio | |
| Mound Family Practice | |
| Miamisburg, Ohio, United States, 45342 | |
| Piqua Family Practice | |
| Piqua, Ohio, United States, 45356 | |
| United States, Virginia | |
| Ettrick Health Center | |
| Ettrick, Virginia, United States, 23803 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01280747 History of Changes |
| Other Study ID Numbers: | A0081247 |
| Study First Received: | January 19, 2011 |
| Last Updated: | June 6, 2012 |
| Health Authority: | United States: Independant Review Board |
Keywords provided by Pfizer:
|
Prior authorization Fibromyalgia Painful Diabetic Peripheral Neuropathy Policy Real World Data |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Pain Peripheral Nervous System Diseases Somatoform Disorders Diabetic Neuropathies Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
Mental Disorders Diabetes Complications Diabetes Mellitus Endocrine System Diseases Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 16, 2013