Clinical trial NCT01280747: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fibromyalgia
Painful Diabetic Peripheral Neuropathy
Keywords: Prior authorization
Fibromyalgia
Painful Diabetic Peripheral Neuropathy
Policy
Real World Data
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-01-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: 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
timeFrame: 6 months
measure: pregabalin
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: pregabalin.
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: healthcare utilization costs (baseline to 6 mo.).
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: 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).
timeFrame: 6 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Osteoporosis Medical Center
state: California
city: Lomita
country: United States
facility: Torrence Clinical Research
state: California
city: Orange
country: United States
facility: Joo-Hyung Lee, MD
state: California
city: Santa Maria
country: United States
facility: Thomas M Dawes Jr. MD
state: California
city: Tulare
country: United States
facility: Tulare Family Practice Medical Group
state: California
city: West Hills
country: United States
facility: Affiliates of Medical Specialties
state: California
city: Atlanta
country: United States
facility: Primary Care Specialists LLC
state: Georgia
city: Augusta
country: United States
facility: Southern Family Medical Center, PC
state: Georgia
city: Hiram
country: United States
facility: WeCareMD, P.C.
state: Georgia
city: Stockbridge
country: United States
facility: Pain Care LLC
state: Georgia
city: Anderson
country: United States
facility: Broadway Family Medicine
state: Indiana
city: Chesterton
country: United States
facility: Duneland Health and Wellness Institute
state: Indiana
city: No Conway
country: United States
facility: Alan S. Goldenhar, DPM
state: New Hampshire
city: Smithtown
country: United States
facility: Endocrine Associates of Long Island, P.C.
state: New York
city: Miamisburg
country: United States
facility: Mound Family Practice
state: Ohio
city: Piqua
country: United States
facility: Piqua Family Practice
state: Ohio
city: Ettrick
country: United States
facility: Ettrick Health Center
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: