Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03953170
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Jorge Vazquez, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

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.

Condition or disease Intervention/treatment Phase
Ileostomy - Stoma Drug: Teduglutide Drug: Placebo Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study subjects will be randomized to Teduglutide or placebo arm in a 1:1 allocation.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Teduglutide

Arm Intervention/treatment
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 Name: Gattex

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Change in daily 24 hr ileostomy collection [ Time Frame: Change from time of surgery to 12 weeks ]
    (mL/day)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953170


Contacts
Layout table for location contacts
Contact: Jorge A Vazquez, MD 412-359-3095 jorge.vazquez@ahn.org

Sponsors and Collaborators
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Shire
Investigators
Layout table for investigator information
Principal Investigator: Jorge A Vazquez, MD Allegheny Health Network

Layout table for additonal information
Responsible Party: Jorge Vazquez, Principal Investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
ClinicalTrials.gov Identifier: NCT03953170     History of Changes
Other Study ID Numbers: Teduglutide
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified study data will be shared with study sponsor (Shire Human Genetics Therapies, Inc)

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Teduglutide
Gastrointestinal Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs