Safety and Efficacy of AST-120 in Patients With Non-Constipating Irritable Bowel Syndrome

NCT00583128 | Completed Phase 2

• 1 other identifier: AST014
• Study Type: interventional
• Target: 117
• Locations: 2 countries
• Sites: 17

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with non-constipating IBS. The study will test whether or not patients receiving AST-120 experience at least a 50% reduction in the number of days with abdominal pain compared to placebo.

Conditions

Irritable Bowel Syndrome

Keywords

IBS; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• Percent of patients who achieve at least a 50% reduction in the number of days with abdominal pain during the final 2 weeks of the double-blind treatment course.

  Eight weeks

• Safety endpoint is adverse events (AEs) deemed possibly, probably, or definitely related to treatment with investigational product during the double-blind treatment course.

  8 weeks

Secondary Outcomes (8)

• Percent change in the IBS QOL score.

  Eight weeks

• Percent change in HADS score.

  8 weeks

• Percent change in Bristol Scale score.

  8 weeks

• Percent change in individual items in the IBS Symptom Severity questionnaire.

  8 weeks

• Durability of effect after the first eight weeks of treatment.

  8 weeks

Study Arms (2)

1

EXPERIMENTAL

AST-120, 2 gram sachets

Drug: AST-120

2

PLACEBO COMPARATOR

Celphere® CP-305, stained to match appearance of AST-120, in 2g sachets

Drug: Celphere® CP-305

Interventions

AST-120 DRUG

oral, sachet, 2 grams three times daily for 8 weeks

1

Celphere® CP-305 DRUG

oral, placebo, sachet, 2 grams three times daily for 8 weeks

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body weight ≥ 40 kg;
• Recurrent abdominal pain or discomfort for three or more days per month for the last three months which meets Rome III criteria for non-constipating IBS;
• Patients on a stable diet for at least eight weeks;
• Patients ≥ 50 years of age with a negative screening colonoscopy in the last five years;
• Able and willing to comply with all protocol procedures for the planned duration of the study;
• Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information,
• Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (intrauterine devices, spermicide and barrier) (Hormonal contraceptives are NOT regarded as adequate for the purpose of this trial.) Partner/spouse sterility may also qualify at the Investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline.

You may not qualify if:

• Constipating IBS;
• History of untreated lactose intolerance;
• History of colonic or major abdominal surgery (colectomy, for example);
• Active (untreated) Thyroid disease;
• Current diagnosis of major depression or psychosis;
• Known positive stool cultures for Clostridium difficile or other pathogens;
• Any condition necessitating the administration of analgesics (except paracetamol), probiotics, neuroleptics, antidepressants for IBS symptoms, daytime tranquilizers, prokinetics or spasmolytic medications;
• Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling;
• Other major physical or major psychiatric illness within the last six months that in the opinion of the investigator would affect the patient's ability to complete the trial;
• Uncontrolled systemic disease such as diabetes;
• Patients undergoing chemotherapy for the treatment of cancer;
• Known hypersensitivity or contraindication to any component of the test product (study drugs) or diagnostics used;
• Participation in another study within eight (8) weeks prior to the study;
• Unable to attend all visits required by the protocol;
• Female patients must be excluded if they are pregnant, breast feeding, or planning to become pregnant during the study.

Sponsors & Collaborators

• Ocera Therapeutics: lead

Study Sites (17)

Clinical Research Associates

Huntsville, Alabama, 35801, United States

Location

Northern California Research

Sacramento, California, 95821, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

Madeleine DuPree, MD

Boynton Beach, Florida, 33436, United States

Location

Michael Epstein, MD

Annapolis, Maryland, 21401, United States

Location

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Long Island Gastrointestinal Research Group

Great Neck, New York, 11023, United States

Location

LeBauer Research Associates

Greensboro, North Carolina, 27403, United States

Location

Peters Medical Research, LLC

High Point, North Carolina, 27262, United States

Location

Ohio Gastroenterology and Liver Institute

Cincinnatti, Ohio, 45219, United States

Location

Oklahoma Foundation for Digestive Disease

Oklahoma City, Oklahoma, 73104, United States

Location

Breco Research LTD

Houston, Texas, 77024, United States

Location

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, 53215, United States

Location

Zuid-Oost Limburg Campus St. Jan

Genk, Genk, 3600, Belgium

Location

UCL St. Luc

Woluwe, Woluwe, 1200, Belgium

Location

AZ St. Lucas Assebroek

Assebroek, 8310, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (5)

• Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.

  PMID: 16678553 BACKGROUND

• Schuster MM. Defining and diagnosing irritable bowel syndrome. Am J Manag Care. 2001 Jul;7(8 Suppl):S246-51.

  PMID: 11474909 BACKGROUND

• Tack J, Broekaert D, Fischler B, Van Oudenhove L, Gevers AM, Janssens J. A controlled crossover study of the selective serotonin reuptake inhibitor citalopram in irritable bowel syndrome. Gut. 2006 Aug;55(8):1095-103. doi: 10.1136/gut.2005.077503. Epub 2006 Jan 9.

  PMID: 16401691 BACKGROUND

• Wood JD. Histamine, mast cells, and the enteric nervous system in the irritable bowel syndrome, enteritis, and food allergies. Gut. 2006 Apr;55(4):445-7. doi: 10.1136/gut.2005.079046.

  PMID: 16531524 BACKGROUND

• Tack JF, Miner PB Jr, Fischer L, Harris MS. Randomised clinical trial: the safety and efficacy of AST-120 in non-constipating irritable bowel syndrome - a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2011 Oct;34(8):868-77. doi: 10.1111/j.1365-2036.2011.04818.x. Epub 2011 Aug 24.

  PMID: 21883322 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

AST 120

Condition Hierarchy (Ancestors)

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

Study Officials

• Jan Tack, MD

  University of Leuven, Department of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: August 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

BE (4); US (13)