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

Fibromyalgia Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00445705
• Other study ID #: 203818-503
• Status: Terminated
• Phase: Phase 2
• First received: March 7, 2007
• Last updated: August 25, 2015
• Start date: March 2007
• Est. completion date: January 2008

Study information

• Verified date: August 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 211
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of fibromyalgia syndrome

• Moderate or severe pain associated with fibromyalgia

Exclusion Criteria:

• Any other uncontrolled disease

• Pregnant or nursing females

Study Design

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• placebo
Part A: Placebo every 12 hours for 4 weeks
• AGN 203818
Part A: AGN 203818 3 mg every 12 hours for 4 weeks
• AGN 203818
Part A: AGN 203818 20 mg every 12 hours for 4 weeks
• AGN 203818
Part A: AGN 203818 60 mg every 12 hours for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, Week 4	No
Secondary	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.	Baseline, Week 4	No
Secondary	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.	Baseline, Week 4	No
Secondary	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.	Week 4	No