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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00445705
Other study ID # 203818-503
Secondary ID
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


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
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