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Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome

This study has been terminated.
(This study was terminated early due to company decision. Part B was never conducted.)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00445705
First received: March 7, 2007
Last updated: December 16, 2011
Last verified: December 2011
History of Changes
  Purpose

This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.


Condition Intervention Phase
Fibromyalgia
 Drug: placebo
Drug: AGN 203818
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Mean Daily-Average-Pain Score at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    Change from Baseline in mean daily-average-pain score at week 4. Patients recorded their daily average pain on a 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable) using a diary during the 4-week treatment period. A negative number change from baseline represents a decrease in average pain (improvement).


Secondary Outcome Measures:
  • Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    Change from baseline in the SF-BPI average pain question score at week 4. The SF-BPI is a patient-rated questionnaire that assesses certain aspects of pain including location, intensity, and interference with certain daily activities. The "average pain" question was rated on an 11-point scale (where 0=no pain and 10=worst pain imaginable). A negative number change from baseline indicates a reduction in average pain.

  • Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    Change from baseline in FIQ total score of physical impairment at week 4. The FIQ is a disease-specific questionnaire consisting of 10 questions and visual analog scales regarding functional disability, pain intensity, sleep function, stiffness, anxiety, depression, and overall sense of wellbeing. Each question is scored from 0 to 10 with 0 = no impairment (best) and 10 indicates maximum impairment (worst), for a minimum possible score (best) of 0 and a maximum possible (worst) total score of 100. A negative number change from baseline indicates improvement.

  • Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    PGIC status for fibromyalgia syndrome at week 4. The PGIC consists of a self-evaluation by the patient of the overall change of their fibromyalgia syndrome since the beginning of the study, rated on a 7-point scale (score of 1-3 = very much improved to minimally improved; 4= no change; 5-7 = minimally worse to very much worse). Results are presented for the percentage of patients reporting each status: "improved"= score of 1-3; "no change"=score of 4; and "worse"=score of 5-7.


Enrollment: 211
Study Start Date: March 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Part A: Placebo every 12 hours for 4 weeks
 Drug: placebo
Part A: Placebo every 12 hours for 4 weeks
Experimental: AGN 203818 3 mg
Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
 Drug: AGN 203818
Part A: AGN 203818 3 mg every 12 hours for 4 weeks
Experimental: AGN 203818 20 mg
Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
 Drug: AGN 203818
Part A: AGN 203818 20 mg every 12 hours for 4 weeks
Experimental: AGN 203818 60 mg
Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
 Drug: AGN 203818
Part A: AGN 203818 60 mg every 12 hours for 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of fibromyalgia syndrome
  • Moderate or severe pain associated with fibromyalgia

Exclusion Criteria:

  • Any other uncontrolled disease
  • Pregnant or nursing females
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445705

Locations
United States, Ohio
Canton, Ohio, United States
Switzerland
Geneva, Switzerland
United Kingdom
Stanmore, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00445705     History of Changes
Other Study ID Numbers: 203818-503
Study First Received: March 7, 2007
Results First Received: December 16, 2011
Last Updated: December 16, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013