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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00321412
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : May 30, 2014
Information provided by (Responsible Party):
Ocera Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Inflammatory Bowel Disease Intestinal Fistula Drug: AST-120 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
  2. Safety: Adverse events deemed possibly, probably or definitely related to study drug during 8 weeks of treatment [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Efficacy: 100% non-draining fistulas at both week 4 and week 8 [ Time Frame: 8 weeks ]
  2. Efficacy: Fistula response at Week 8 [ Time Frame: 8 weeks ]
  3. Efficacy: Change in CDAI scores from baseline over 8 weeks of treatment [ Time Frame: 8 weeks ]
  4. Safety: Clinical laboratory tests (electrolytes) [ Time Frame: 8 weeks ]
  5. Safety: Development of abscesses [ Time Frame: 8 weeks ]
  6. Safety: Physical examination, vital signs (blood pressure, heart rate, respiration rate and temperature) [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00321412

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Sponsors and Collaborators
Ocera Therapeutics
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Study Director: Laurent Fischer, MD Ocera Therapeutics

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Responsible Party: Ocera Therapeutics Identifier: NCT00321412    
Other Study ID Numbers: AST001
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014
Keywords provided by Ocera Therapeutics:
Crohn's disease
Inflammatory Bowel Disease
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Intestinal Fistula
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Digestive System Fistula