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

NCT03953170 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: Teduglutide
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• Change in daily 24 hr ileostomy collection

  (mL/day)

  Change from time of surgery to 12 weeks

Study Arms (2)

Teduglutide

ACTIVE COMPARATOR

Teduglutide 0.05 g/kg/day

Drug: Teduglutide

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Teduglutide DRUG

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.

Also known as: Gattex

Teduglutide

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• Shire: collaborator

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Interventions

teduglutide; ALX-0600

Study Officials

• James McCormick, DO

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The drug will be delivered to the patient according to the randomization scheme and neither the patient nor the investigators will know which patient is randomized into which group until the study is completed. Only the pharmacist at the AHN pharmacy will know the patient assigned to each group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Study subjects will be randomized to Teduglutide or placebo arm in a 1:1 allocation.

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: May 16, 2019
• Study Start: June 2, 2022
• Primary Completion: November 25, 2022
• Study Completion: December 29, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)