Fibromyalgia of Less Than One Year Duration. Study of Pregabalin

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Don L. Goldenberg MD, Newton-Wellesley Hospital
ClinicalTrials.gov Identifier:
NCT01397006
First received: July 15, 2011
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Drug: Pregabalin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fibromyalgia of Less Than One Year Duration in Primary Care: Treatment Response in a Double Blind, Placebo Controlled Study of Pregabalin

Resource links provided by NLM:


Further study details as provided by Newton-Wellesley Hospital:

Primary Outcome Measures:
  • Change in pain VAS from study entry to end of study [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in total score FIQ from study entry to last visit. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in total score FM 2010 Clinical Scale from study entry to last visit. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in PGIC from study entry to last visit. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in total score for HRQOL from study entry to last visit. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin Drug: Pregabalin
Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg
Other Name: Lyrica
Placebo Comparator: Placebo Drug: Pregabalin
Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg
Other Name: Lyrica

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397006

Locations
United States, Massachusetts
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
Sponsors and Collaborators
Newton-Wellesley Hospital
Pfizer
Investigators
Principal Investigator: Don Goldenberg, MD Newton-Wellesley Hospital
  More Information

Publications:

Responsible Party: Don L. Goldenberg MD, PI, Newton-Wellesley Hospital
ClinicalTrials.gov Identifier: NCT01397006     History of Changes
Other Study ID Numbers: N11-507
Study First Received: July 15, 2011
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Newton-Wellesley Hospital:
Fibromyalgia
pregabalin
Lyrica

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 17, 2014