Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain

NCT00441766 | Terminated Phase 2 Results

• 1 other identifier: 203818-008
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

This study will explore the safety and effectiveness of different doses of AGN 203818 in relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Highest-Average-Pain Score at Week 4

  Change from baseline in mean highest-average-pain score at Week 4. The mean highest-average-pain score was the average of the 7 highest daily-average-pain scores obtained over the 14 days prior to the Week 4 visit. Patients recorded their daily-average-pain on an 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable). A negative number change from baseline represents a decrease in average pain (improvement).

  Baseline, Week 4

Secondary Outcomes (3)

• Percentage of Patients Who Rated Their Condition as Improved on the Subject Global Impression of Change (SGIC) at Week 4

  Week 4

• Percentage of Patients Who Experienced Adequate Relief of Irritable Bowel Syndrome (IBS) Pain (AR-IBS) at Week 4

  Week 4

• Change From Baseline in Frequency of Bowel Movements at Week 4 Using the Bristol Stool Scale (BSS)

  Baseline, Week 4

Study Arms (4)

AGN 203818 3 mg

EXPERIMENTAL

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

Drug: AGN 203818

AGN 203818 20 mg

EXPERIMENTAL

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

Drug: AGN 203818

AGN 203818 60 mg

EXPERIMENTAL

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

Drug: AGN 203818

Placebo

PLACEBO COMPARATOR

Part A: Placebo capsule every 12 hours for 4 weeks

Drug: placebo

Interventions

AGN 203818 DRUG

Part A: 3 mg AGN203818 capsule every 12 hours for 4 weeks

AGN 203818 3 mg

placebo DRUG

Part A: placebo capsule every 12 hours for 4 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Irritable Bowel Syndrome
• Moderate or severe IBS pain

You may not qualify if:

• Any other uncontrolled disease
• Pregnant or nursing females

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Orange, California, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Limitations and Caveats

Only Part A results are presented; Due to termination of the study, 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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2007
• First Posted: March 1, 2007
• Study Start: March 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: January 20, 2012
• Results First Posted: January 20, 2012

Record last verified: 2011-12

Locations

US (1)