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Sponsored by: |
Ocera Therapeutics |
Information provided by: | Ocera Therapeutics |
ClinicalTrials.gov Identifier: | NCT00583531 |
This is an open-label pilot study in which all patients will receive AST-120 for 4 weeks. Patients will discontinue antibiotics at study entry. They may continue other previously prescribed treatments (e.g., probiotics and/or nutritional agents) at the discretion of the study doctor. The purpose of the study is to assess whether the investigational medication AST-120 will be a safe and effective treatment for the symptoms of pouchitis, a chronic inflammatory condition, in patients whose symptoms have not responded well to antibiotics. An initial group of 10 patients will be enrolled. If there are no serious side effects associated with the study drug and at least 3 of the 10 patients respond, a second group of 10 patients may be enrolled. Patients will have clinic visits at the start of the study and at week 4. Patients will be checked by phone on a weekly basis for symptom response, compliance and development of side effects. Endoscopies will be performed at the start of the study and at week 4 or early termination.
Condition | Intervention | Phase |
Pouchitis |
Drug: AST-120 |
Phase II |
MedlinePlus related topics: | Antibiotics Nausea and Vomiting |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study of the Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis |
Estimated Enrollment: | 20 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
I: Experimental
Active treatment with AST-120
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Drug: AST-120
Oral, 2 grams TID in sachets for 4 weeks
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Show Detailed Description |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |||||
Mayo Clinic, Inflammatory Bowel Disease Clinic | |||||
Rochester, Minnesota, United States, 55905 |
Ocera Therapeutics |
Principal Investigator: | Darrell S. Pardi, MD | Mayo Clinic College of Medicine |
Responsible Party: | Mayo Clinic ( Darrell Pardi, MD ) |
Study ID Numbers: | 06-007216 |
First Received: | December 20, 2007 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00583531 |
Health Authority: | United States: Food and Drug Administration |
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