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

NCT00583531 | Terminated Phase 2

• 1 other identifier: 06-007216
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pouchitis

Keywords

Antibiotic-refractory Pouchitis; Pouchitis; Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• Response as defined by a decrease in the Pouchitis Diseases Activity Index (PDAI) score of at least 3 points

  4 weeks

• Safety: Any adverse events (AEs) deemed possibly, probably, or definitely related to treatment with investigational product during 4 weeks of treatment

  4 weeks

Secondary Outcomes (9)

• Remission, as defined as a PDAI score of less than 7 points

  4 weeks

• Reduction of PDAI clinical symptom subscore of at least 1 point

  4 weeks

• Reduction of PDAI endoscopic subscore of at least 1 point

  4 weeks

• Reduction of PDAI histology subscore of at least 1 point

  4 weeks

• 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

  4 weeks

Study Arms (1)

I

EXPERIMENTAL

Active treatment with AST-120

Drug: AST-120

Interventions

AST-120 DRUG

Oral, 2 grams TID in sachets for 4 weeks

I

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ocera Therapeutics: lead

Study Sites (1)

Mayo Clinic, Inflammatory Bowel Disease Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (63)

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  BACKGROUND

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• Tremaine WJ, Sandborn WJ, Kenan ML. Bismuth subsalicylate tablets for chronic antibiotic-resistant pouchitis. Gastroenterology 114:A1101, 1998.

  BACKGROUND

• Wischmeyer P, Pemberton JH, Phillips SF. Chronic pouchitis after ileal pouch-anal anastomosis: responses to butyrate and glutamine suppositories in a pilot study. Mayo Clin Proc. 1993 Oct;68(10):978-81. doi: 10.1016/s0025-6196(12)62270-8.

  PMID: 8412364 BACKGROUND

• Tremaine WJ, Sandborn WJ, Wolff BG, Carpenter HA, Zinsmeister AR, Metzger PP. Bismuth carbomer foam enemas for active chronic pouchitis: a randomized, double-blind, placebo-controlled trial. Aliment Pharmacol Ther. 1997 Dec;11(6):1041-6. doi: 10.1046/j.1365-2036.1997.00253.x.

  PMID: 9663827 BACKGROUND

MeSH Terms

Conditions

Pouchitis; Colitis, Ulcerative

Interventions

AST 120

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases; Colitis; Inflammatory Bowel Diseases; Colonic Diseases

Study Officials

• Darrell S. Pardi, MD

  Mayo Clinic College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

US (1)