NCT01280747

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

17 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

January 26, 2021

Status Verified

June 1, 2012

Enrollment Period

1.2 years

First QC Date

January 19, 2011

Last Update Submit

January 22, 2021

Conditions

FibromyalgiaPainful Diabetic Peripheral Neuropathy

Keywords

Prior authorizationFibromyalgiaPainful Diabetic Peripheral NeuropathyPolicyReal World Data

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (6)

  • 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

  • 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

  • +1 more secondary outcomes

Study Arms (4)

1

Eligible fibromyalgia patients receive usual care with pregabalin prior authorization requirements in place

Other: prior authorization

2

Eligible fibromyalgia patients receive usual care without pregabalin prior authorization requirements in place

Other: no prior authorization

3

Eligible painful diabetic peripheral neuropathy patients receive usual care with pregabalin prior authorization requirements in place

Other: prior authorization

4

Eligible painful diabetic peripheral neuropathy patients receive usual care without pregabalin prior authorization requirements in place

Other: no prior authorization

Interventions

prior authorizationOTHER

This is a naturalistic study. The physician will prescribe medication(s) as appropriate

1
no prior authorizationOTHER

This is a naturalistic study. The physician will prescribe medication(s) as appropriate

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Osteoporosis Medical Center

Beverly Hills, California, 90211, United States

Location

Torrence Clinical Research

Lomita, California, 90717, United States

Location

Joo-Hyung Lee, MD

Orange, California, 92868, United States

Location

Thomas M Dawes Jr. MD

Santa Maria, California, 93455, United States

Location

Tulare Family Practice Medical Group

Tulare, California, 93274, United States

Location

Affiliates of Medical Specialties

West Hills, California, 91307, United States

Location

Primary Care Specialists LLC

Atlanta, Georgia, 30312, United States

Location

Southern Family Medical Center, PC

Augusta, Georgia, 30906, United States

Location

WeCareMD, P.C.

Hiram, Georgia, 30141, United States

Location

Pain Care LLC

Stockbridge, Georgia, 30281, United States

Location

Broadway Family Medicine

Anderson, Indiana, 46012, United States

Location

Duneland Health and Wellness Institute

Chesterton, Indiana, 46304, United States

Location

Alan S. Goldenhar, DPM

No Conway, New Hampshire, 03860, United States

Location

Endocrine Associates of Long Island, P.C.

Smithtown, New York, 11787, United States

Location

Mound Family Practice

Miamisburg, Ohio, 45342, United States

Location

Piqua Family Practice

Piqua, Ohio, 45356, United States

Location

Ettrick Health Center

Ettrick, Virginia, 23803, United States

Location

Related Links

MeSH Terms

Conditions

Fibromyalgia

Interventions

Prior Authorization

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Insurance, HealthInsuranceFinancing, OrganizedEconomicsHealth Care Economics and Organizations

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 21, 2011

Study Start

January 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

January 26, 2021

Record last verified: 2012-06

Locations

US(17)