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Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis

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ClinicalTrials.gov Identifier: NCT00583531
Recruitment Status : Terminated (Lack of enrollment)
First Posted : December 31, 2007
Last Update Posted : June 18, 2014
Sponsor:
Information provided by (Responsible Party):
Ocera Therapeutics

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Pouchitis Drug: AST-120 Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis
Study Start Date : March 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: I
Active treatment with AST-120
 Drug: AST-120
Oral, 2 grams TID in sachets for 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Response as defined by a decrease in the Pouchitis Diseases Activity Index (PDAI) score of at least 3 points [ Time Frame: 4 weeks ]
  2. Safety: Any adverse events (AEs) deemed possibly, probably, or definitely related to treatment with investigational product during 4 weeks of treatment [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Remission, as defined as a PDAI score of less than 7 points [ Time Frame: 4 weeks ]
  2. Reduction of PDAI clinical symptom subscore of at least 1 point [ Time Frame: 4 weeks ]
  3. Reduction of PDAI endoscopic subscore of at least 1 point [ Time Frame: 4 weeks ]
  4. Reduction of PDAI histology subscore of at least 1 point [ Time Frame: 4 weeks ]
  5. Need for rescue medication/quantity of antidiarrheal medication used during the last week of the trail compared to usage in the week prior to study entry [ Time Frame: 4 weeks ]
  6. Quality of Life as measured by the Cleveland Global QoL instrument and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [ Time Frame: 4 weeks ]
  7. Significant change in clinical laboratory tests [ Time Frame: 4 weeks ]
  8. Worsening GI symptoms (diarrhea, abdominal pain, urgency or bleeding) or new GI and extra-GI symptoms (e.g., headache, nausea, vomiting, constipation) [ Time Frame: 4 weeks ]
  9. Significant change in physical examination, including vital signs (blood pressure, heart rate, respiration rate and temperature) [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with active pouchitis (defined as having a PDAI score > 7) after IPAA for UC, despite at least 14 days of antibiotic therapy. Active pouchitis must be confirmed by endoscopy and histology within 4 weeks of study entry
  • Able to give informed consent
  • Able and willing to comply with all study procedures

Exclusion Criteria:

  • Patients previously treated with infliximab or any investigational immunosuppressant/ immunomodulator for pouchitis
  • Patients undergoing chemotherapy for the treatment of cancer
  • Presence of other inflammatory diseases of the pouch: Crohn's disease, Cuffitis, active specific infection of the pouch: (e.g., CMV, C. difficile)
  • History of non-inflammatory disease of the pouch: decreased pouch compliance, irritable pouch syndrome, afferent or efferent limb obstruction, stricture of pouch
  • Ileal pouch patients with familial adenomatous polyposis
  • History of other diarrheal illnesses: lactose intolerance, celiac disease, small bowel bacterial overgrowth
  • Primary Sclerosing Cholangitis with or without liver transplant
  • Uncontrolled systemic disease
  • Needing oral or topical 5-ASA, cholestyramine, steroids or immunomodulators
  • 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
  • Women who are pregnant, breast feeding, or planning to become pregnant during the study
  • Women of child-bearing potential who are not willing to use barrier or depot contraception methods
  • Use of NSAIDs or aspirin (>3 times per week) within the past 3 weeks
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00583531


Locations
United States, Minnesota
Mayo Clinic, Inflammatory Bowel Disease Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Ocera Therapeutics
Investigators
Principal Investigator: Darrell S. Pardi, MD Mayo Clinic College of Medicine
More Information
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Publications:
Sandborn WJ. Pouchitis: risk factors, frequency, natural history, classification and public health perspective. Kluwer Academic Publishers, 1997.
Salfiti N, Loftus EV, Tremaine WJ, Pardi DS, et al. Clinical features and outcomes of cytomegalovirus colitis or pouchitis in patients with inflammatory bowel disease. Am J Gastroenterol 100:S316, 2005
Gionchetti P, Rizzello F, Morselli C, et al. Eight-week trial of oral budesonide for the treatment of refractory pouchitis. Gastroenterology 126:A123, 2004
Tremaine WJ, Sandborn WJ, Kenan ML. Bismuth subsalicylate tablets for chronic antibiotic-resistant pouchitis. Gastroenterology 114:A1101, 1998.

Responsible Party: Ocera Therapeutics
ClinicalTrials.gov Identifier: NCT00583531     History of Changes
Other Study ID Numbers: 06-007216
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: June 18, 2014
Last Verified: June 2014

Keywords provided by Ocera Therapeutics:
Antibiotic-refractory Pouchitis
Pouchitis
Ulcerative Colitis

Additional relevant MeSH terms:
Pouchitis
Ileitis
Enteritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Ileal Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents