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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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01280747
First received: January 19, 2011
Last updated: June 6, 2012
Last verified: June 2012
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Diabetic Neuropathies
Fibromyalgia
Myofascial Pain Syndromes
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014