Primary outcomeMean· Baseline, Up to 8 weeks
Change in Average 3-day Fistula Percent Volume
| Group | Value (Percent change in fistula volume) | Spread |
|---|---|---|
| Teduglutide Intervention | 76.33 | 355.36 |
| Standard of Care Intervention | 441.67 | 824.87 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataTeduglutide for Enterocutaneous Fistula (ECF)
NCTNCT02889393 (opens ClinicalTrials.gov in a new tab)Other id20170189
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 6 participants (actual)
- Sponsor
- Daniel Dante Yeh · Other
- Design
- Randomized · Single masking
- Countries
1 country
United States
- Start
- 31 Jan 2019
- Primary completion
- 15 Jul 2020
- Completion
- 15 Jul 2021
- First posted
- 5 Sept 2016 (estimated)
- Last update posted
- 6 Oct 2021
- Conditions
- Postoperative Fistula
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2019202020212022
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to determine whether Teduglutide is safe and feasible to be given for the treatment of enterocutaneous fistula (ECF). The hypothesis is that the drug will be well tolerated and will improve the volume of daily ECF output as well as improve the functional quality of life.
Interventions
- TeduglutideDrug
- Standard of CareOther
Arms2
Experimental
Standard of Care followed by Teduglutide
Participants in this group will receive standard of care treatment for the first 8 weeks followed by daily Teduglutide for the next 8 weeks. Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure.
Experimental
Teduglutide followed by Standard of Care
Participants in this group will receive daily Teduglutide treatment for the first 8 weeks followed by standard of care for the next 8 weeks. Subjects with a favorable response will be offered an open label extension during which they will continue to receive teduglutide for up to another 12 months or permanent fistula closure
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Average 3-day Fistula Percent Volume
Time frame · Baseline, Up to 8 weeks
Registry description
Percent fistula volume will be reported from the participant
Secondary outcomes(8)
Number of Participants With Ceased Fistula Output
Time frame · Up to 16 weeks
Registry description
As evaluated by treating physician of having at least 1 ceased fistula output
Quality of Life as Measured by ASCQ-Me® v2.0 Social Functioning - Short Form
Time frame · Up to 16 weeks
Registry description
Adult Sickle Cell Quality of Life Measurement (ASCQ-Me) Version 2.0 Social Functioning - Short Form questionnaire has a total score ranging from 5-25 with the higher score indicating a healthier status.
Quality of Life as Measured by the ASCQ-Me® v2.0 Sleep Impact - Short Form
Time frame · Up to 16 weeks
Registry description
Adult Sickle Cell Quality of Life Measurement (ASCQ-Me) Version 2.0 Sleep Impact - Short Form questionnaire has a total score ranging from 5-25 with the higher score indicating a healthier status
Quality of Life as Measured by the PROMIS Scale v1.2 - Global Health
Time frame · Up to 16 weeks
Registry description
Patient Reported Outcome Measures Information Systems Global Health has a total score ranging from 10-50 with the higher score indicating a healthier status
Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Belly Pain 5a
Time frame · Up to 16 weeks
Registry description
Patient Reported Outcome Measures Information Systems (PROMIS-GI) Gastrointestinal Belly Pain 5a questionnaire has a total score ranging from 1-25 with the lower score indicating a healthier status
Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Diarrhea 6a
Time frame · Up to 16 weeks
Registry description
Patient Reported Outcome Measures Information Systems (PROMIS-GI) Gastrointestinal Diarrhea 6a questionnaire has a total score ranging from 1-30 with the lower score indicating a healthier status
Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Nausea and Vomiting 4a
Time frame · Up to 16 weeks
Registry description
Patient Reported Outcome Measures Information Systems (PROMIS-GI) Gastrointestinal Nausea and Vomiting 4a questionnaire has a total score ranging from 1-20 with the lower score indicating a healthier status
Quality of Life as Measured by the PROMIS Scale v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a
Time frame · Up to 16 weeks
Registry description
Patient Reported Outcome Measures Information Systems (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 8a questionnaire has a total score ranging from 8-40 with the lower score indicating a healthier status
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeCount of participants· Up to 16 weeks
Number of Participants With Ceased Fistula Output
| Group | Value (Participants) |
|---|---|
| All Participants | 3 |
Secondary outcomeMedian· Up to 16 weeks
Quality of Life as Measured by ASCQ-Me® v2.0 Social Functioning - Short Form
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Teduglutide Intervention | 20.5 | 5.2 |
| Standard of Care Intervention | 20 | 7.7 |
Secondary outcomeMedian· Up to 16 weeks
Quality of Life as Measured by the ASCQ-Me® v2.0 Sleep Impact - Short Form
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Teduglutide Intervention | 19.5 | 1.3 |
| Standard of Care Intervention | 19.5 | 4.1 |
Secondary outcomeMedian· Up to 16 weeks
Quality of Life as Measured by the PROMIS Scale v1.2 - Global Health
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Teduglutide Intervention | 30 | 6.3 |
| Standard of Care Intervention | 35 | 10.2 |
Secondary outcomeMedian· Up to 16 weeks
Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Belly Pain 5a
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Teduglutide Intervention | 6.0 | 8.2 |
| Standard of Care Intervention | 7.5 | 6.9 |
Secondary outcomeMedian· Up to 16 weeks
Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Diarrhea 6a
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Teduglutide Intervention | 8.0 | 4.4 |
| Standard of Care Intervention | 6.0 | 4.0 |
Secondary outcomeMedian· Up to 16 weeks
Quality of Life as Measured by the PROMIS Scale v1.0 - Gastrointestinal Nausea and Vomiting 4a
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Teduglutide Intervention | 3.0 | 2.8 |
| Standard of Care Intervention | 3.5 | 3.3 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| On TeduglutideThe study is a crossover design. All participants received 8 weeks of daily Teduglutide. Teduglutide: Daily 0.05 mg/kg Teduglutide administered subcutaneously. | 0 / 6 | 0 / 6 | 6 / 6 |
| On Standard of CareThe study is a crossover design. All participants received 8 weeks of daily Standard of Care Therapy. Standard of Care: The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion. | 0 / 6 | 0 / 6 | 2 / 6 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
Studies with results
2 studies on this page
Indexing hint: Randomized controlled trial · 2022
4 results
Teduglutide for the treatment of low-output enterocutaneous fistula - A pilot randomized controlled study.
Yeh et al. 2022Clinical nutrition ESPENcited by 4
PMID 35871951DOI 10.1016/j.clnesp.2022.04.031PUB-35871951
Full text at the publisher4 results
Indexing hint: Randomized controlled trial · 2011
8 results
Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome.
Jeppesen et al. 2011Gutcited by 323
PMID 21317170PMC3112364DOI 10.1136/gut.2010.218271PUB-21317170
Free to read · publisher termsCC BY-NC8 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Age \>18
* Enterocutaneous fistula (ECF) that could be secondary to volvulus, injury, prior trauma or surgery, or vascular ischemia
Exclusion Criteria:
* Perianal fistula
* Clinical suspicion of inflammatory bowel disease
* History of radiation enteritis or sprue (as defined by history)
* Active (\<1 year) alcohol or drug abuse
* Significant hepatic, or cardiac diseases as defined as:
* Hepatic: aspartate aminotransferase (AST) \> 2 times upper limit of normal (10-40 U/L)
* Cardiac: unstable angina or evidence of active myocardial ischemia (elevated troponin level drawn by clinical suspicion)
* Severe renal dysfunction: serum creatinine \> 2 times upper limit of normal (0.6-1.5 mg/dL)
* Received glutamine less than 4 weeks prior to screening
* Receiving growth factors (erythropoietin, granulocyte colony-stimulating factor, granulo-cyte-macrophage colony stimulating factor, and human growth hormone)
* Pregnancy or lactation (women of childbearing age will be excluded if they do not agree to either complete sexual abstinence during the study or if they refuse to use at least two forms of highly effective contraception such as oral contraception, injectable or implantable contraception, vaginal rings, or intrauterine devices (IUD))
* Active malignancy or suspicion for gastrointestinal malignancy on CT scan
* Not capable of understanding or not willing to adhere to the study visit schedule and drug administration requirements
* Family history of intestinal malignancy (gastric, small intestine, colon)
* Personal or family history of hereditary non-polyposis colorectal cancer, familial adenomatous polyposis, first degree relative with colon cancer
* Positive hemoccult (per rectum)
* Abnormal baseline electrocardiogram (ECF) suggestive of congestive heart failure or underlying cardiac disease
* Taking oral benzodiazepines, barbiturates, or phenothiazines
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