Current partner codePEPTIDESDE
NCT03953170·Phase 3·INTERVENTIONAL

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

Status

Withdrawn

Phase

Phase 3

Enrollment

0

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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.

DRUG

Placebo

Placebo

Timeline

From registration to results.

  1. First posted

    May 16, 2019

  2. Study start

    Jun 2, 2022

  3. Primary completion

    Nov 25, 2022

  4. Study completion

    Dec 29, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Feb 23, 2023

Outcomes

What the study measures.

Primary outcomes

Change in daily 24 hr ileostomy collection

Time frame · Change from time of surgery to 12 weeks

(mL/day)

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Teduglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.