ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00445705
Recruitment Status : Terminated (This study was terminated early due to company decision. Part B was never conducted.)
First Posted : March 9, 2007
Results First Posted : January 20, 2012
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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 or disease Intervention/treatment Phase
Fibromyalgia Drug: placebo Drug: AGN 203818 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : March 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change From Baseline in Mean Daily-Average-Pain Score at Week 4 [ Time Frame: Baseline, Week 4 ]
    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 :
  1. Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4 [ Time Frame: Baseline, Week 4 ]
    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.

  2. Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4 [ Time Frame: Baseline, Week 4 ]
    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.

  3. Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4 [ Time Frame: Week 4 ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00445705     History of Changes
Other Study ID Numbers: 203818-503
First Posted: March 9, 2007    Key Record Dates
Results First Posted: January 20, 2012
Last Update Posted: September 7, 2015
Last Verified: August 2015

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