FibromyalgiaNCT01280747
Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study
An observational study of Fibromyalgia and Painful Diabetic Peripheral Neuropathy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 17 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Painful Diabetic Peripheral Neuropathy
- What is being tested?
- prior authorization and no prior authorization
- How many people
- 42 participants
- Where
- 17 sitesUnited States
- Study dates
- Jan 2011to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Broadway Family Medicine
Anderson, Indiana, 46012
Primary Care Specialists LLC
Atlanta, Georgia, 30312
Southern Family Medical Center, PC
Augusta, Georgia, 30906
Osteoporosis Medical Center
Beverly Hills, California, 90211
Duneland Health and Wellness Institute
Chesterton, Indiana, 46304
Ettrick Health Center
Ettrick, Virginia, 23803
WeCareMD, P.C.
Hiram, Georgia, 30141
Torrence Clinical Research
Lomita, California, 90717
Mound Family Practice
Miamisburg, Ohio, 45342
Alan S. Goldenhar, DPM
No Conway, New Hampshire, 03860
Joo-Hyung Lee, MD
Orange, California, 92868
Piqua Family Practice
Piqua, Ohio, 45356
Thomas M Dawes Jr. MD
Santa Maria, California, 93455
Endocrine Associates of Long Island, P.C.
Smithtown, New York, 11787
Pain Care LLC
Stockbridge, Georgia, 30281
Tulare Family Practice Medical Group
Tulare, California, 93274
Affiliates of Medical Specialties
West Hills, California, 91307
About this study
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.
Read the 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.
- Being tested
- prior authorization, no prior authorization
- Keywords
- Prior authorization, Fibromyalgia, Painful Diabetic Peripheral Neuropathy, Policy, Real World Data
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prior authorizationOther
This is a naturalistic study. The physician will prescribe medication(s) as appropriate
no prior authorizationOther
This is a naturalistic study. The physician will prescribe medication(s) as appropriate
prior authorizationOther
This is a naturalistic study. The physician will prescribe medication(s) as appropriate
no prior authorizationOther
This is a naturalistic study. The physician will prescribe medication(s) as appropriate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Eligible fibromyalgia patients receive usual care with pregabalin prior authorization requirements in place Receives: Other: prior authorization | |
| 2 | Eligible fibromyalgia patients receive usual care without pregabalin prior authorization requirements in place Receives: Other: no prior authorization | |
| 3 | Eligible painful diabetic peripheral neuropathy patients receive usual care with pregabalin prior authorization requirements in place Receives: Other: prior authorization | |
| 4 | Eligible painful diabetic peripheral neuropathy patients receive usual care without pregabalin prior authorization requirements in place Receives: Other: no prior authorization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
pregabalin
Measured: 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
Measured: 6 months
pregabalin.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months
healthcare utilization costs (baseline to 6 mo.).
Measured: 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.
Measured: 6 months
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280747
- Sponsor's protocol ID
- A0081247
- Status last verified
- Jun 2012
- First submitted
- 19 Jan 2011
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study
- ClinicalTrials.gov ID
- NCT01280747
- Acronym / sponsor ID
- A0081247
- Keywords
- Prior authorization, Fibromyalgia, Painful Diabetic Peripheral Neuropathy, Policy, Real World Data
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: prior authorizationEligible fibromyalgia patients receive usual care with pregabalin prior authorization requirements in place |
| 2 | – | Other: no prior authorizationEligible fibromyalgia patients receive usual care without pregabalin prior authorization requirements in place |
| 3 | – | Other: prior authorizationEligible painful diabetic peripheral neuropathy patients receive usual care with pregabalin prior authorization requirements in place |
| 4 | – | Other: no prior authorizationEligible painful diabetic peripheral neuropathy patients receive usual care without pregabalin prior authorization requirements in place |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prior authorizationThis is a naturalistic study. The physician will prescribe medication(s) as appropriate | Other | 1 |
| no prior authorizationThis is a naturalistic study. The physician will prescribe medication(s) as appropriate | Other | 2 |
| prior authorizationThis is a naturalistic study. The physician will prescribe medication(s) as appropriate | Other | 3 |
| no prior authorizationThis is a naturalistic study. The physician will prescribe medication(s) as appropriate | Other | 4 |
Primary outcome
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
pregabalin
Time frame: 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
Time frame: 6 months
pregabalin.
Time frame: 6 months
6 secondary outcomes
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
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
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
healthcare utilization costs (baseline to 6 mo.).
Time frame: 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.
Time frame: 6 months
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
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Painful Diabetic Peripheral Neuropathy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.