Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00445705

Purpose

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	Intervention	Phase
Fibromyalgia	Drug: placebo Drug: AGN203818 Drug: AGN 203818	Phase II

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:

Reduction in daily pain scores [ Time Frame: Part A: Week 4; Part B: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Short Form Brief Pain Inventory [ Time Frame: Part A: Week 4; Part B: Week 12 ] [ Designated as safety issue: No ]
Short Form McGill Pain questionnaire [ Time Frame: Part A: Week 4; Part B: Week 12 ] [ Designated as safety issue: No ]
Fibromyalgia Impact Questionnaire [ Time Frame: Part A: Week 4; Part B: Week 12 ] [ Designated as safety issue: No ]
Patient Global Impression of Change [ Time Frame: Part A: Week 4; Part B: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	650
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Part A: Placebo every 12 hours for 4 weeks	Drug: placebo Part A: Placebo every 12 hours for 4 weeks
2: Experimental Part A: 3 mg AGN 203818 every 12 hours for 4 weeks	Drug: AGN203818 Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
3: Experimental Part A: 20 mg AGN 203818 every 12 hours for 4 weeks	Drug: AGN203818 Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
4: Experimental Part A: 60 mg AGN 203818 every 12 hours for 4 weeks	Drug: AGN203818 Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
5: Placebo Comparator Part B: placebo every 12 hours for 12 weeks	Drug: placebo Part B: Placebo every 12 hours for 12 weeks
6: Experimental Part B: 20 mg AGN 203818 every 12 hours for 12 weeks	Drug: AGN 203818 Part B: 20 mg AGN 203818 every 12 hours for 12 weeks
7: Experimental Part B: 100 mg AGN 203818 every 12 hours for 12 weeks	Drug: AGN 203818 Part B: 100 mg AGN 203818 every 12 hours for 12 weeks
8: Experimental Part B: 160 mg AGN 203818 every 12 hours for 12 weeks	Drug: AGN 203818 Part B: 160 mg AGN 203818 every 12 hours for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445705

Locations

United States, Ohio

Cincinnati, Ohio, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	203818-503
Study First Received:	March 7, 2007
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00445705 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Nervous System Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 06, 2009