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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

March 7, 2007
December 16, 2011
March 2007
January 2008   (final data collection date for primary outcome measure)
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).
Reduction in daily pain scores
Complete list of historical versions of study NCT00445705 on ClinicalTrials.gov Archive Site
  • 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.
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Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome
Not Provided

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.
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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: placebo
    Part A: Placebo every 12 hours for 4 weeks
  • Drug: AGN 203818
    Part A: AGN 203818 3 mg every 12 hours for 4 weeks
  • Drug: AGN 203818
    Part A: AGN 203818 20 mg every 12 hours for 4 weeks
  • Drug: AGN 203818
    Part A: AGN 203818 60 mg every 12 hours for 4 weeks
  • Placebo Comparator: Placebo
    Part A: Placebo every 12 hours for 4 weeks
    Intervention: Drug: placebo
  • Experimental: AGN 203818 3 mg
    Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
    Intervention: Drug: AGN 203818
  • Experimental: AGN 203818 20 mg
    Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
    Intervention: Drug: AGN 203818
  • Experimental: AGN 203818 60 mg
    Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
    Intervention: Drug: AGN 203818
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
211
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Any other uncontrolled disease
  • Pregnant or nursing females
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Switzerland,   United Kingdom
 
NCT00445705
203818-503
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Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP