Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications

The objective of the study is to investigate the natural history of patients with a temporary ileostomy and to assess the effect of Teduglutide in reducing morbidity, hospital readmissions and post reversal complications.

Study Overview

• Status: Withdrawn
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: Drug: Placebo; Drug: Teduglutide

Detailed Description

This is a prospective, controlled, randomized, double blind study. A total of 36 subjects will be enrolled into the study. Subjects will be randomized to receive Teduglutide or Placebo for 12 weeks or until the ileostomy is reversed. Teduglutide or placebo will be administered via a daily subcutaneous injection into the abdomen or thigh. The sites will be rotated with each injection. If adverse effects develop the subjects will be permitted to hold drug administration for a maximum of 5 days in total during the 12-week study.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: James McCormick, DO; Phone Number: 412-359-3091; Email: James.mccormick@ahn.org

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are undergoing temporary ileostomy (loop or end ileostomy) regardless of the indication or technique used (open or laparoscopy) as part of their regular standard of care
• Age- 18-80 years old
• Normal routine laboratories (CMP, CBC, CRP, amylase, lipase)
• Permitted medications will include biologicals which dose has not been changed for > 6 months, and immunosuppressant therapy which dose has not been changed for 3 months (i.e. codeine sulfate, loperamide, or Lomotil)

Exclusion Criteria:

• Emergency need for ileostomy
• Pregnant or nursing
• Malnutrition or requiring parenteral or enteral nutrition
• Known intestinal obstruction, stricture, or adhesions that would predispose the patient to the development of intestinal obstruction, perforation, hemorrhage, or intestinal abscess
• Intestinal fistulas or abscess proximal to the ostomy
• Small bowel resection greater than 50 cm.
• Clinically significant cardiovascular, renal, pulmonary, endocrine, immunologic, dermatology, neurological or psychiatric disorders
• Cholelithiasis or pancreatitis
• Family history of colorectal cancer or familial polyposis
• Cancer in the last 5 years
• History of HIV, Hepatitis B or C, or other acute systemic or intestinal infections requiring antibiotics
• Use of GLP1 analogues which may increase the risk of acute pancreatitis
• Treatment of Octreotide

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Active Comparator: Teduglutide; Teduglutide 0.05 g/kg/day	Drug: Teduglutide; Teduglutide (Gattex, Shire) was approved by the FDA in 2012 for use in adult patients with short bowel syndrome requiring parenteral support only. The results of this study will not be used to justify a change of indication, or dose currently approved for Teduglutide, and will not be used to advertise the drug. This study meets all of the requirements for exemption from the IND regulations and an IND exemption has been confirmed by the FDA.; Other Names: Gattex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in daily 24 hr ileostomy collection	(mL/day)	Change from time of surgery to 12 weeks

Collaborators and Investigators

• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Collaborators: Shire

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Actual): November 25, 2022
• Study Completion (Actual): December 29, 2022

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Protective Agents; Radiation-Protective Agents; Teduglutide
• Other Study ID Numbers: Teduglutide

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified study data will be shared with study sponsor (Shire Human Genetics Therapies, Inc)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes