NCT00057278

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2003

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 31, 2003

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

December 19, 2007

Status Verified

December 1, 2007

First QC Date

March 28, 2003

Last Update Submit

December 14, 2007

Conditions

Fibromyalgia

Keywords

Gabapentin

Outcome Measures

Primary Outcomes (1)

  • Brief Pain Inventory (BPI) average pain item

Secondary Outcomes (9)

  • Fibromyalgia Impact Questionnaire

  • Mean Tender Point Pain Threshold

  • McGill Pain Questionnaire

  • Clinical Global Impression of Severity

  • Patient Global Impression of Improvement

  • +4 more secondary outcomes

Interventions

gabapentinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

McLean Hospital/Harvard Medical School (must live in the Boston, MA area)

Belmont, Massachusetts, 02478, United States

Location

Newton-Wellesley Hospital (must live in the Boston, MA area)

Newton, Massachusetts, 02462, United States

Location

University of Cincinnati College of Medicine, Department of Psychiatry (must live in the Cincinnati, OH area)

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Lesley M. Arnold, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 28, 2003

First Posted

March 31, 2003

Study Start

March 1, 2003

Study Completion

January 1, 2006

Last Updated

December 19, 2007

Record last verified: 2007-12

Locations

US(3)