Fibromyalgia of Less Than One Year Duration. Study of Pregabalin

NCT01397006

Last updated date
Study Location
Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- • Meet the 2010 ACR criteria for diagnosis of fibromyalgia (See Appendix)

- Meet the 1990 ACR criteria for the classification of fibromyalgia (See Appendix)

- Patients have a pain VAS > 4

- Patients are able to understand and sign informed consent

- Patients are able to understand and complete study questionnaires

- Patients are prepared to discontinue all pain medications including non-steroidal anti-inflammatory drugs (NSAIDs), and medications for sleep or mood disturbances two weeks prior to beginning the study. Acetaminophen, up to 2 extra-strength, three times daily, will be allowed for break-through pain. Medication use will be surveyed at each visit (See Appendix).

- Age - > 18

- Females with no documented evidence of current pregnancy, and willingness to take the necessary precautions to prevent pregnancy for the duration of the study period

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- • Patients with a significant musculoskeletal or rheumatic disorder that may confuse
the diagnosis


- Any subject with suicidal thoughts in the past or currently


- Patient with a history of renal disease, heart disease, bleeding problems or low
platelet counts


- Women who are breast feeding


- Men or women who plan to have children during the course of the study


- Unable to discontinue any medications prescribed for pain, other than
acetaminophen, or any medications for sleep or mood disturbances for at least 2
weeks before the study


- Unable to discontinue any mediations used for sleep disturbances


- Patients currently being treated for any psychiatric illness including depression
or anxiety disorder


- Patients currently taking antidepressant, anti-anxiety, or antipsychotic
medications.


- Inability to understand and sign informed consent and complete questionnaires.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Fibromyalgia of Less Than One Year Duration. Study of Pregabalin
Official Title  ICMJE Fibromyalgia of Less Than One Year Duration in Primary Care: Treatment Response in a Double Blind, Placebo Controlled Study of Pregabalin
Brief Summary The purpose of the study is to evaluate whether pregabalin is effective in treating subjects who have had fibromyalgia for less than one year. Pregabalin has been approved by the FDA for treatment of fibromyalgia. the purpose of the study is to see if subjects identified through their primary care physicians who have fibromyalgia and have had symptoms for less than one year respond to pregabalin and to identify characteristics of that response.
Detailed Description

The randomized clinical trial of pregabalin in early-onset fibromyalgia.

At the baseline visit, each subject will be asked if they wish to consider enrolling in Part II. If they agree, the details of the study will be explained and Dr Goldenberg will consent those who wish to enroll in Part II. The first 75 patients who consent will be enrolled in the study, the randomized clinical trial of pregabalin in early-onset fibromyalgia.

After a study subject has been enrolled, they will be randomized to one of two treatment groups. All subjects will be randomized, 1:1 either to the pregabalin group (group A) or the placebo group (group B). Randomization will take place after enrollment via selection of one of a multitude of envelopes containing a random number. Each random number will have been preassigned to either Group A or group B.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE Drug: Pregabalin
Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg
Other Name: Lyrica
Study Arms  ICMJE
  • Experimental: Pregabalin
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: Pregabalin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 11, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2011)
76
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ? Meet the 2010 ACR criteria for diagnosis of fibromyalgia (See Appendix)

    • Meet the 1990 ACR criteria for the classification of fibromyalgia (See Appendix)
    • Patients have a pain VAS > 4
    • Patients are able to understand and sign informed consent
    • Patients are able to understand and complete study questionnaires
    • Patients are prepared to discontinue all pain medications including non-steroidal anti-inflammatory drugs (NSAIDs), and medications for sleep or mood disturbances two weeks prior to beginning the study. Acetaminophen, up to 2 extra-strength, three times daily, will be allowed for break-through pain. Medication use will be surveyed at each visit (See Appendix).
    • Age - > 18
    • Females with no documented evidence of current pregnancy, and willingness to take the necessary precautions to prevent pregnancy for the duration of the study period

Exclusion Criteria:

  • ? Patients with a significant musculoskeletal or rheumatic disorder that may confuse the diagnosis

    • Any subject with suicidal thoughts in the past or currently
    • Patient with a history of renal disease, heart disease, bleeding problems or low platelet counts
    • Women who are breast feeding
    • Men or women who plan to have children during the course of the study
    • Unable to discontinue any medications prescribed for pain, other than acetaminophen, or any medications for sleep or mood disturbances for at least 2 weeks before the study
    • Unable to discontinue any mediations used for sleep disturbances
    • Patients currently being treated for any psychiatric illness including depression or anxiety disorder
    • Patients currently taking antidepressant, anti-anxiety, or antipsychotic medications.
    • Inability to understand and sign informed consent and complete questionnaires.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01397006
Other Study ID Numbers  ICMJE N11-507
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Don L. Goldenberg MD, Newton-Wellesley Hospital
Study Sponsor  ICMJE Newton-Wellesley Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Don Goldenberg, MDNewton-Wellesley Hospital
PRS Account Newton-Wellesley Hospital
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP