Ileostomy - StomaPhase 3NCT03953170
Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
A Phase 3 study testing Teduglutide in people with Ileostomy - Stoma, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ileostomy - Stoma
- What is being tested?
- Teduglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2022to 29 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
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.
Read the 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.
- Conditions
- Ileostomy - Stoma
- Being tested
- Teduglutide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeduglutideDrug
Also called Gattex
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.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Teduglutide | Active comparator | Teduglutide 0.05 g/kg/day Receives: Drug: Teduglutide |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily 24 hr ileostomy collection
(mL/day)
Measured: Change from time of surgery to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start2 Jun 2022
- Primary completion25 Nov 2022
- Study completion29 Dec 2022
Why it stopped: Funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileostomy - StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study subjects will be randomized to Teduglutide or placebo arm in a 1:1 allocation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Principal investigator, James McCormick, DO, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- James McCormick, DO, Principal investigator, Allegheny Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953170
- Sponsor's protocol ID
- Teduglutide
- Status last verified
- Feb 2023
- First submitted
- 15 Apr 2019
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified study data will be shared with study sponsor (Shire Human Genetics Therapies, Inc)
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
- ClinicalTrials.gov ID
- NCT03953170
- Acronym / sponsor ID
- Teduglutide
- Conditions
- Ileostomy - Stoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding ended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Collaborators
- Shire
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 29 Dec 2022 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Study subjects will be randomized to Teduglutide or placebo arm in a 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| Teduglutide | Active comparator | Drug: TeduglutideTeduglutide 0.05 g/kg/day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeduglutideAlso: GattexTeduglutide (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 | Teduglutide |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in daily 24 hr ileostomy collection
Time frame: Change from time of surgery to 12 weeks
(mL/day)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No. De-identified study data will be shared with study sponsor (Shire Human Genetics Therapies, Inc)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James McCormick, DO principal investigator
Allegheny Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Teduglutide in people with Ileostomy - Stoma, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily 24 hr ileostomy collection (time frame: Change from time of surgery to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.