Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study

Fibromyalgia Clinical Trial

Official title:

Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01280747
• Other study ID #: A0081247
• Status: Terminated
• Start date: January 2011
• Est. completion date: April 2012

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Painful Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases
• Somatoform Disorders

Intervention

Other:
• prior authorization
This is a naturalistic study. The physician will prescribe medication(s) as appropriate
• no prior authorization
This is a naturalistic study. The physician will prescribe medication(s) as appropriate
• prior authorization
This is a naturalistic study. The physician will prescribe medication(s) as appropriate
• no prior authorization
This is a naturalistic study. The physician will prescribe medication(s) as appropriate

Locations

Country	Name	City	State
United States	Broadway Family Medicine	Anderson	Indiana
United States	Primary Care Specialists LLC	Atlanta	Georgia
United States	Southern Family Medical Center, PC	Augusta	Georgia
United States	Osteoporosis Medical Center	Beverly Hills	California
United States	Duneland Health and Wellness Institute	Chesterton	Indiana
United States	Ettrick Health Center	Ettrick	Virginia
United States	WeCareMD, P.C.	Hiram	Georgia
United States	Torrence Clinical Research	Lomita	California
United States	Mound Family Practice	Miamisburg	Ohio
United States	Alan S. Goldenhar, DPM	No Conway	New Hampshire
United States	Joo-Hyung Lee, MD	Orange	California
United States	Piqua Family Practice	Piqua	Ohio
United States	Thomas M Dawes Jr. MD	Santa Maria	California
United States	Endocrine Associates of Long Island, P.C.	Smithtown	New York
United States	Pain Care LLC	Stockbridge	Georgia
United States	Tulare Family Practice Medical Group	Tulare	California
United States	Affiliates of Medical Specialties	West Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	pregabalin		6 months
Primary	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
Primary	pregabalin.		6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	healthcare utilization costs (baseline to 6 mo.).		6 months
Secondary	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
Secondary	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

External Links

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