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

NCT00445705 | Terminated Phase 2 Results

• 1 other identifier: 203818-503
• Study Type: interventional
• Target: 211
• Locations: 3 countries
• Sites: 3

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4

  Baseline, Week 4

• Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4

  Baseline, Week 4

• Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4

  Week 4

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Part A: Placebo every 12 hours for 4 weeks

Drug: placebo

AGN 203818 3 mg

EXPERIMENTAL

Part A: 3 mg AGN 203818 every 12 hours for 4 weeks

Drug: AGN 203818

AGN 203818 20 mg

EXPERIMENTAL

Part A: 20 mg AGN 203818 every 12 hours for 4 weeks

Drug: AGN 203818

AGN 203818 60 mg

EXPERIMENTAL

Part A: 60 mg AGN 203818 every 12 hours for 4 weeks

Drug: AGN 203818

Interventions

placebo DRUG

Part A: Placebo every 12 hours for 4 weeks

Placebo

AGN 203818 DRUG

Part A: AGN 203818 3 mg every 12 hours for 4 weeks

AGN 203818 3 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any other uncontrolled disease
• Pregnant or nursing females

Sponsors & Collaborators

• Allergan: lead

Study Sites (3)

Unknown Facility

Canton, Ohio, United States

Location

Unknown Facility

Geneva, Switzerland

Location

Unknown Facility

Stanmore, United Kingdom

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

This study was terminated early due to company decision. Only Part A results are presented; Part B was never conducted.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 9, 2007
• Study Start: March 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: September 7, 2015
• Results First Posted: January 20, 2012

Record last verified: 2015-08

Locations

US (1); CH (1); GB (1)