Back to resultsSafety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome
Primary Purpose
Fibromyalgia
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
placebo
AGN 203818
AGN 203818
AGN 203818
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of fibromyalgia syndrome
- Moderate or severe pain associated with fibromyalgia
Exclusion Criteria:
- Any other uncontrolled disease
- Pregnant or nursing females
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
AGN 203818 3 mg
AGN 203818 20 mg
AGN 203818 60 mg
Arm Description
Part A: Placebo every 12 hours for 4 weeks
Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
Outcomes
Primary Outcome Measures
Change From Baseline in Mean Daily-Average-Pain Score at 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
Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at 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.
Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at 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.
Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00445705
Brief Title
Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early due to company decision. Part B was never conducted.
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
211 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Part A: Placebo every 12 hours for 4 weeks
Arm Title
AGN 203818 3 mg
Arm Type
Experimental
Arm Description
Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
Arm Title
AGN 203818 20 mg
Arm Type
Experimental
Arm Description
Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
Arm Title
AGN 203818 60 mg
Arm Type
Experimental
Arm Description
Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Part A: Placebo every 12 hours for 4 weeks
Intervention Type
Drug
Intervention Name(s)
AGN 203818
Intervention Description
Part A: AGN 203818 3 mg every 12 hours for 4 weeks
Intervention Type
Drug
Intervention Name(s)
AGN 203818
Intervention Description
Part A: AGN 203818 20 mg every 12 hours for 4 weeks
Intervention Type
Drug
Intervention Name(s)
AGN 203818
Intervention Description
Part A: AGN 203818 60 mg every 12 hours for 4 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Daily-Average-Pain Score at Week 4
Description
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).
Time Frame
Baseline, Week 4
Secondary Outcome Measure Information:
Title
Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4
Description
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.
Time Frame
Baseline, Week 4
Title
Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4
Description
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.
Time Frame
Baseline, Week 4
Title
Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4
Description
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.
Time Frame
Week 4
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of fibromyalgia syndrome
Moderate or severe pain associated with fibromyalgia
Exclusion Criteria:
Any other uncontrolled disease
Pregnant or nursing females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Canton
State/Province
Ohio
Country
United States
City
Geneva
Country
Switzerland
City
Stanmore
Country
United Kingdom
12. IPD Sharing Statement
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Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome
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