Gabapentin in Fibromyalgia Trial (GIFT)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00057278
First received: March 28, 2003
Last updated: December 14, 2007
Last verified: December 2007
  Purpose

This study will assess the safety and effectiveness of the drug gabapentin in reducing pain associated with primary fibromyalgia.


Condition Intervention Phase
Fibromyalgia
Drug: gabapentin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Gabapentin in Fibromyalgia Trial (GIFT)

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • Brief Pain Inventory (BPI) average pain item

Secondary Outcome Measures:
  • Fibromyalgia Impact Questionnaire
  • Mean Tender Point Pain Threshold
  • McGill Pain Questionnaire
  • Clinical Global Impression of Severity
  • Patient Global Impression of Improvement
  • Montgomery-Asberg Depression Rating Scale (MADRS)
  • Medical Outcomes Study Short Form-36 (SF-36)
  • Medical Outcomes Sleep Scale (MOS-Sleep)
  • Fibromyalgia Rating Scale (FRS)

Estimated Enrollment: 150
Study Start Date: March 2003
Study Completion Date: January 2006
Detailed Description:

Fibromyalgia, a chronic musculoskeletal pain disorder of unknown etiology, is characterized by widespread musculoskeletal pain, fatigue, and multiple tender points; the disease affects 3 to 6 million Americans. A person is considered to have fibromyalgia if he or she has widespread pain in combination with tenderness in at least 11 of 18 specific tender point sites.

Treatment of fibromyalgia requires a comprehensive approach and includes aerobic exercise, heat and massage, antidepressant medications, and relaxation. Gabapentin, a medication used to treat seizures, has been shown to work on pain transmission pathways and may relieve the pain associated with fibromyalgia. This study will assess the efficacy of gabapentin in reducing pain severity in fibromyalgia as measured by the average pain item of the Brief Pain Inventory (BPI) score.

Patients will be randomized to receive gabapentin or placebo. The gabapentin dose will be titrated for persisting symptoms and as tolerated during the first 6 weeks of the study, reaching final doses between 1800 mg/day and 2400 mg/day. Patients will then continue on the final dose for the remaining 6 weeks of the study. Following completion of the 12 week treatment phase, patients will be tapered off of the medication over 1 week.

The effectiveness of gabapentin will be assessed using the BPI. The BPI is a self-administered questionnaire that measures the severity of pain and the interference of pain on function over the past 24 hours. Other assessments will include the total Fibromyalgia Impact Questionnaire (FIQ) score; six 11-point Likert-type scales in the FIQ that measure pain, fatigue, morning tiredness, stiffness, anxiety, and depression; the mean tender point pain threshold; Clinical Global Impression of Severity (CGI-Severity); Patient Global Impression of Improvement (PGI-Improvement); the Short-form McGill Pain Questionnaire (SF-MPQ); the Medical Outcomes Study Short Form-36 (SF-36); the Montgomery Asberg Depression Rating Scale (MADRS); and the Medical Outcomes Sleep Scale (MOS-Sleep).

  Eligibility

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

Inclusion Criteria:

  • Primary fibromyalgia as defined by the American College of Rheumatology (ACR)
  • Score greater than 4 on the average pain item of the BPI at screening
  • Ability to understand and cooperate with study procedures
  • Acceptable methods of contraception

Exclusion Criteria:

  • Unwillingness or inability to provide written informed consent.
  • Lifetime history of psychosis, hypomania or mania, epilepsy, or dementia
  • History of seizures or status epilepticus
  • DSM-IV diagnosis of alcohol or substance dependence with the exception of nicotine dependence within 6 months prior to screening visit
  • A positive urine drug screen for any substances of abuse or excluded medication. (NOTE: If the participant has a positive drug screen at Visit 1 for an excluded medication that may not have had an adequate wash-out period, a retest may be performed prior to Visit 2. If the retest is positive, the participant will be excluded.)
  • Serious suicide risk
  • Treatment refractory in the opinion of study official
  • Pregnant or breastfeeding
  • Clinically unstable medical or psychiatric condition that could interfere with the absorption, metabolism, excretion, or safety of gabapentin or interfere with the assessment of disease severity
  • Thyroid-stimulating hormone (TSH) concentrations outside the range of 0.30-8.0 UlU/mL. (NOTE: Participants who have been on a stable dose of thyroid supplementation for at least the past 3 months, have medically appropriate TSH values, and are clinically euthyroid may participate in the study.)
  • Any screening laboratory assay that is outside of the local laboratories' normal range by more than 20% or is deemed to be a clinically significant abnormality by the investigator, with the exception of liver function tests (AST, ALT, alkaline phosphatase) which must be within 1.5 X upper limit of normal
  • Inability to exclude traumatic injury, regional or structural rheumatic disease, or infectious arthropathy as the etiology of their relevant symptoms and that would interfere with interpretation of outcome measures (e.g., osteoarthritis, bursitis, tendonitis)
  • History of an autoimmune disease or inflammatory arthritis, such as systemic lupus erythematosis (SLE) or rheumatoid arthritis (RA).
  • An abnormal Westergren erythrocyte sedimentation rate (e.g., ESR > 40 mm/min)
  • An abnormal antinuclear antibody (ANA > 1:160) or rheumatoid factor (RF >15 IU/ml)
  • Treatment with a monoamine oxidase inhibitor, tricyclic, SSRI antidepressant (with the exception of fluoxetine), or lithium within 2 weeks prior to beginning study medication
  • Treatment with fluoxetine within 30 days prior to beginning study medication
  • Treatment with analgesic medication (with the exception of acetaminophen and over-the-counter NSAIDs) within 1 week prior to beginning study medication
  • Treatment with any other excluded medications that cannot be discontinued at the screening visit (see Table 2 for a list of excluded medications)
  • Previous treatment with gabapentin
  • Previous treatment with pregabalin
  • Treatment with any other investigational medications within 30 days prior to screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057278

Locations
United States, Massachusetts
McLean Hospital/Harvard Medical School (must live in the Boston, MA area)
Belmont, Massachusetts, United States, 02478
Newton-Wellesley Hospital (must live in the Boston, MA area)
Newton, Massachusetts, United States, 02462
United States, Ohio
University of Cincinnati College of Medicine, Department of Psychiatry (must live in the Cincinnati, OH area)
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Investigators
Principal Investigator: Lesley M. Arnold, MD University of Cincinnati
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00057278     History of Changes
Other Study ID Numbers: N01 AR22264, NIAMS-089
Study First Received: March 28, 2003
Last Updated: December 14, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Gabapentin

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on July 23, 2014