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

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Ocera Therapeutics
ClinicalTrials.gov Identifier:
NCT00583531
First received: December 20, 2007
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ocera Therapeutics:

Primary Outcome Measures:
  • Response as defined by a decrease in the Pouchitis Diseases Activity Index (PDAI) score of at least 3 points [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Remission, as defined as a PDAI score of less than 7 points [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Reduction of PDAI clinical symptom subscore of at least 1 point [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Reduction of PDAI endoscopic subscore of at least 1 point [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Reduction of PDAI histology subscore of at least 1 point [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Quality of Life as measured by the Cleveland Global QoL instrument and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Significant change in clinical laboratory tests [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Significant change in physical examination, including vital signs (blood pressure, heart rate, respiration rate and temperature) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Active treatment with AST-120
Drug: AST-120
Oral, 2 grams TID in sachets for 4 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: 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

Publications:
Shepherd NA, Hulten L, Tytgat GN, et al. Workshop: Pouchitis. Int J Colorectal Dis 4:205-29, 1989.
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
Study First Received: December 20, 2007
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014