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Trial · Interventional

WithdrawnPhase 3Registry data

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

NCTNCT03953170 (opens ClinicalTrials.gov in a new tab)Other idTeduglutide
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 3
Enrollment
0 participants (actual)
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
2 Jun 2022
Primary completion
25 Nov 2022
Completion
29 Dec 2022
First posted
16 May 2019
Last update posted
23 Feb 2023
Conditions
Ileostomy - Stoma

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222023
  1. Ph 3

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

    NCT03953170

    2 Jun 2022 to 29 Dec 2022

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TeduglutideDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Teduglutide

    Teduglutide 0.05 g/kg/day

  • Placebo comparator

    Placebo

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in daily 24 hr ileostomy collection

    Time frame · Change from time of surgery to 12 weeks

    Registry description

    (mL/day)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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