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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ocera Therapeutics
ClinicalTrials.gov Identifier:
NCT00583128
First received: December 20, 2007
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: AST-120
Drug: Celphere® CP-305
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Patients With Non-Constipating Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Ocera Therapeutics:

Primary Outcome Measures:
  • 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. [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
  • Safety endpoint is adverse events (AEs) deemed possibly, probably, or definitely related to treatment with investigational product during the double-blind treatment course. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent change in the IBS QOL score. [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
  • Percent change in HADS score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Percent change in Bristol Scale score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Percent change in individual items in the IBS Symptom Severity questionnaire. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Durability of effect after the first eight weeks of treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in clinical laboratory tests from Baseline to Week 8 and to Week 18. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Any adverse event occurring after Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Physical examinations, vital signs (blood pressure, heart rate, respiration and temperature). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 117
Study Start Date: August 2007
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AST-120, 2 gram sachets
Drug: AST-120
oral, sachet, 2 grams three times daily for 8 weeks
Placebo Comparator: 2
Celphere® CP-305, stained to match appearance of AST-120, in 2g sachets
Drug: Celphere® CP-305
oral, placebo, sachet, 2 grams three times daily for 8 weeks

Detailed Description:

Patients experiencing non-constipating IBS will be randomized to one of two arms in the study: the experimental drug AST-120 or placebo. Patients will take 2g of AST-120 or placebo three times per day for eight weeks. After the 8 week course, patients will receive an additional 8 weeks single blind treatment, after a one week washout period.

The experimental drug AST-120 is composed of black, odorless spherical carbon particles in 2g sachets (aluminum foil pouches). The placebo consists of microcrystalline cellulose spheres, Celphere CP-305 stained to match the appearance of AST-120, in 2g sachets (aluminum foil pouches). Both AST-120 and placebo are oral (taken by mouth) preparations. Both are tasteless. To take the product, patients will tear open the sachet, drop the contents directly on their tongue and wash it down with 8 ounces of water.

Patients will be expected to participate in up to 10 visits, approximately three by telephone and the remainder of visits are in-clinic. At these visits, patients will undergo a number of tests including: hematology panel, lactose intolerance testing, physical exams, pregnancy tests, evaluations based on the following scales: The Bristol Stool Scale, IBS Severity Scale, IBS Quality of Life, SCL-90R.

Provided the patient has been stable for eight weeks prior to their baseline visit, they will be allowed to take the following medications: drugs that inhibit gastric secretion (histamine blockers, proton pump inhibitors), benzodiazepines and Imidazopyridines (short acting, nonbenzodiazepine hypnotics) for sleep (dose must be consistent with the use of a sleep agent) aspirin at a cardiovascular prophylactic dose (75-150 mg/day) and paracetamol. Antidepressants for non-IBS symptoms are allowed. Loperamide will be permitted as a rescue for diarrhea only when patients are experiencing at least 3 liquid or soft stools in one day. However, Loperamide is prohibited during the two week screening period.

Patients will not be allowed to take the following medications whilst on trial and these therapies must have been discontinued by at least two weeks prior to their baseline visit: probiotics, neuroleptics, antidepressants for IBS symptoms, daytime tranquilizers, prokinetics, spasmolytics, analgesics, other investigational agents and any over-the-counter medications.

Patient will be required to keep a diary during the study

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583128

Locations
United States, Alabama
Clinical Research Associates
Huntsville, Alabama, United States, 35801
United States, California
Northern California Research
Sacramento, California, United States, 95821
Medical Center for Clinical Research
San Diego, California, United States, 92108
United States, Florida
Madeleine DuPree, MD
Boynton Beach, Florida, United States, 33436
United States, Maryland
Michael Epstein, MD
Annapolis, Maryland, United States, 21401
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
United States, New York
Long Island Gastrointestinal Research Group
Great Neck, New York, United States, 11023
United States, North Carolina
LeBauer Research Associates
Greensboro, North Carolina, United States, 27403
Peters Medical Research, LLC
High Point, North Carolina, United States, 27262
United States, Ohio
Ohio Gastroenterology and Liver Institute
Cincinnatti, Ohio, United States, 45219
United States, Oklahoma
Oklahoma Foundation for Digestive Disease
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Breco Research LTD
Houston, Texas, United States, 77024
United States, Wisconsin
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215
Belgium
AZ St. Lucas Assebroek
Assebroek, Belgium, 8310
Zuid-Oost Limburg Campus St. Jan
Genk, Belgium, 3600
UZ Leuven
Leuven, Belgium, 3000
UCL St. Luc
Woluwe, Belgium, 1200
Sponsors and Collaborators
Ocera Therapeutics
Investigators
Principal Investigator: Jan Tack, MD University of Leuven, Department of Gastroenterology
  More Information

Publications:
Responsible Party: Ocera Therapeutics
ClinicalTrials.gov Identifier: NCT00583128     History of Changes
Other Study ID Numbers: AST014
Study First Received: December 20, 2007
Last Updated: June 2, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
United States: Food and Drug Administration

Keywords provided by Ocera Therapeutics:
IBS
Irritable Bowel Syndrome

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014