Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ocera Therapeutics
ClinicalTrials.gov Identifier:
NCT00321412
First received: May 1, 2006
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohn's disease symptoms versus patients who receive placebo (material that does not contain any active medication).


Condition Intervention Phase
Inflammatory Bowel Disease
Intestinal Fistula
Drug: AST-120
Phase 3

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 Mild to Moderately Active Crohn's Patients With Fistulas

Resource links provided by NLM:


Further study details as provided by Ocera Therapeutics:

Primary Outcome Measures:
  • Efficacy: The proportion of patients considered to be "treatment successes" defined by a reduction of at least 50% in the number of draining fistulas at both week 4 and week 8 of an 8 week treatment period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Safety: Adverse events deemed possibly, probably or definitely related to study drug during 8 weeks of treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy: 100% non-draining fistulas at both week 4 and week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Efficacy: Fistula response at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Efficacy: Change in CDAI scores from baseline over 8 weeks of treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Safety: Clinical laboratory tests (electrolytes) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Safety: Development of abscesses [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Safety: Physical examination, vital signs (blood pressure, heart rate, respiration rate and temperature) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 191
Study Start Date: March 2006
Study Completion Date: September 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Celphere® CP-305, stained to match appearance of AST-120, in 2g sachets
Drug: AST-120
oral, sachet, 2 grams three times daily for 8 weeks
Experimental: 1
AST-120, 2 gram sachets
Drug: AST-120
oral, sachet, 2 grams three times daily for 8 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Weight > or = 40kg
  • Documented diagnosis of Crohn's disease, including patients with documented diagnosis of ileitis, colitis, or ileocolitis
  • Presence of at least one draining fistula. Patients with enterocutaneous fistulas can be included if they have > or = 1 draining perianal fistula. Women with rectovaginal fistulas can be included if they have > or = 1 draining perianal fistula.
  • Crohn's Disease Activity Index (CDAI) score < 400
  • Platelet count (thrombocytes) > or = 100,000/uL
  • Able and willing to comply with all protocol procedures for the 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 (hormonal contraceptives, intrauterine devices, spermicide and barrier). 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:

  • Non-response to infliximab or other biological immunosuppressants/ immunomodulators for fistulas associated with Crohn's disease (response is defined as a > or = 50% reduction from baseline in the number of fistulas over at least four weeks); patients who respond once to infliximab and eventually fail can be included
  • Infliximab (and/or other biological immunosuppressant/immunomodulatory) therapy within 3 months prior to enrollment in the study
  • Presence of symptomatic strictures or suggestion of significant clinical obstruction
  • Patients with setons are excluded, unless the setons are removed within 48 hours prior to study entry
  • Presence of entero-entero, recto-vesicular, entero-vesicular fistulas
  • Platelet count (thrombocytes) < 100,000/uL
  • CDAI score of > or = 400
  • Patient is unable to stay on a stable dose of concomitant Crohn's disease medication(s) for at least 10 weeks in the opinion of the investigator
  • Currently symptomatic untreated diarrhea due to conditions other than mild to moderately active Crohn's disease (e.g., bacterial or parasitic gastroenteritis, bile salt diarrhea, etc.)
  • Severe diarrhea defined by > 10 liquid bowel movements per day
  • Other local manifestations of mild to moderately active Crohn's disease such as abscesses, or other disease manifestations for which surgery might be indicated or which might preclude utilization of a CDAI to assess response to therapy (e.g., short bowel syndrome)
  • Presence of an ileostomy
  • Receiving Total Parenteral Nutrition (TPN) as the sole source of nutrition within 3 weeks of Screen
  • Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling.
  • Hemoglobin < 8.5 g/dL (females) or hemoglobin < 10 g/dL (males) at Screen
  • Women who are pregnant, breast feeding, or planning to become pregnant during the study
  • Other major physical or major psychiatric illness within the last 6 months that in the opinion of the investigator would affect the patient's ability to complete the trial
  • Uncontrolled systemic disease
  • 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
  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: NCT00321412

  Show 88 Study Locations
Sponsors and Collaborators
Ocera Therapeutics
Investigators
Study Director: Laurent Fischer, MD Ocera Therapeutics
  More Information

Publications:

Responsible Party: Ocera Therapeutics
ClinicalTrials.gov Identifier: NCT00321412     History of Changes
Other Study ID Numbers: AST001
Study First Received: May 1, 2006
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
Netherlands: Dutch Health Care Inspectorate
Hungary: National Institute of Pharmacy
Austria: Agency for Health and Food Safety
Israel: Ministry of Health

Keywords provided by Ocera Therapeutics:
Crohn's disease
IBD
Inflammatory Bowel Disease
Fistula

Additional relevant MeSH terms:
Fistula
Inflammatory Bowel Diseases
Intestinal Diseases
Intestinal Fistula
Digestive System Diseases
Digestive System Fistula
Gastroenteritis
Gastrointestinal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 22, 2014