Trial · NCT02099084
Short Bowel Syndrome and Teduglutide Versus Placebo
NCT02099084, Phase 4, Completed, Mayo Clinic; results first posted 2016-02-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Short Bowel Syndrome and Teduglutide Versus Placebo. Trials, record NCT02099084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02099084
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Short Bowel Syndrome and Teduglutide Versus Placebo
- NCT number
- NCT02099084
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 8 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Short Bowel Syndrome
- Interventions
- Teduglutide, Placebo
- First posted
- 2014-03-28
- Last updated
- 2016-02-22
- Results first posted
- 2016-02-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Gastric Emptying Half-Time (T1/2) | approximately 2 hours after radiolabeled meal is ingested | The time for half of the ingested solids or liquids to leave the stomach. |
| Primary | Overall Gut Transit | baseline, approximately 6 hours after ingestion of radiolabeled meal | Given the variable extent of the residual length of the small intestine and colon, the proportion emptied from the body at 6 hours was assessed as an overall estimate of the whole gut transit. The 6-hour values for intra-abdominal counts were then compared with the 100% reference values of counts (at time zero, which is immediately after ingestion of the radiolabeled meal) to determine the percentage of isotope retained in the abdomen. 100% minus the percentage of retained isotope reflected the amount emptied from the GI tract. |
| Secondary | Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol | baseline, approximately 2 hours and 8 hours after ingestion of radiolabeled meal | Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry. |
| Secondary | Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Lactulose at 2 Hours | baseline, approximately 2 hours after ingestion of radiolabeled meal | Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry. |
| Secondary | Change in Small Intestinal and Colonic Permeability as Measured by Lactulose/Mannitol Ratio at 2 Hours | baseline, approximately 2 hours after ingestion of radiolabeled meal | Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry. |
| Other | Stool Weight at 8 Hours | approximately 8 hours after ingestion of radiolabeled meal | After an overnight fast, subjects received a single dose of placebo or Teduglutide 1 hour before breakfast, then consumed a radiolabeled meal. After 8 hours a stool collection was taken. |
| Other | Urine Volume at 8 Hours | Start of the ingestion of the radiolabeled meal until 8 hours after the meal | After an overnight fast, subjects received a single dose of placebo or Teduglutide 1 hour before breakfast, then consumed a radiolabeled meal. Urine was collected twice: from the start of the ingestion of the meal to 2 hours, and 2-8 hours. The total volume of urine collected was the sum of these two collections. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Gastric Emptying Half-Time (T1/2) | approximately 2 hours after radiolabeled meal is ingested | minutes | MEAN | |
| SECONDARY | Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol | baseline, approximately 2 hours and 8 hours after ingestion of radiolabeled meal | mg | MEAN | |
| PRIMARY | Overall Gut Transit | baseline, approximately 6 hours after ingestion of radiolabeled meal | Percentage of isotope emptied | MEAN | |
| SECONDARY | Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Lactulose at 2 Hours | baseline, approximately 2 hours after ingestion of radiolabeled meal | mg | MEAN | |
| SECONDARY | Change in Small Intestinal and Colonic Permeability as Measured by Lactulose/Mannitol Ratio at 2 Hours | baseline, approximately 2 hours after ingestion of radiolabeled meal | ratio | MEAN | |
| OTHER_PRE_SPECIFIED | Stool Weight at 8 Hours | approximately 8 hours after ingestion of radiolabeled meal | g | MEAN | |
| OTHER_PRE_SPECIFIED | Urine Volume at 8 Hours | Start of the ingestion of the radiolabeled meal until 8 hours after the meal | mL | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Gastric Emptying Half-Time (T1/2) | Teduglutide | 113 | Standard Deviation 16 | minutes | |
| Gastric Emptying Half-Time (T1/2) | Placebo | 106 | Standard Deviation 20 | minutes | |
| Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol | Teduglutide | 0 - 2 hours | 16.2 | Standard Error 3.6 | mg |
| Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol | Placebo | 0 - 2 hours | 11.3 | Standard Error 2.2 | mg |
| Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol | Teduglutide | 0 - 8 hours | 48.8 | Standard Error 8.9 | mg |
| Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol | Placebo | 0 - 8 hours | 32.7 | Standard Error 5.9 | mg |
| Overall Gut Transit | Teduglutide | 53.4 | Standard Deviation 15 | Percentage of isotope emptied | |
| Overall Gut Transit | Placebo | 62.4 | Standard Deviation 15.2 | Percentage of isotope emptied | |
| Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Lactulose at 2 Hours | Teduglutide | 0.42 | Standard Deviation 0.14 | mg | |
| Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Lactulose at 2 Hours | Placebo | 0.38 | Standard Deviation 0.14 | mg |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Teduglutide First, Then Placebo | 4 | |
| First Intervention | STARTED | Placebo First, Then Teduglutide | 4 | |
| First Intervention | COMPLETED | Teduglutide First, Then Placebo | 4 | |
| First Intervention | COMPLETED | Placebo First, Then Teduglutide | 4 | |
| First Intervention | NOT COMPLETED | Teduglutide First, Then Placebo | 0 | |
| First Intervention | NOT COMPLETED | Placebo First, Then Teduglutide | 0 | |
| Washout Period of 14 Days | STARTED | Teduglutide First, Then Placebo | 4 | |
| Washout Period of 14 Days | STARTED | Placebo First, Then Teduglutide | 4 | |
| Washout Period of 14 Days | COMPLETED | Teduglutide First, Then Placebo | 4 | |
| Washout Period of 14 Days | COMPLETED | Placebo First, Then Teduglutide | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Moderate abdominal discomfort | Gastrointestinal disorders | Teduglutide | 0 | 8 | 0 |
| other | Moderate abdominal discomfort | Gastrointestinal disorders | Placebo | 1 | 8 | 2 |
| other | Headache | General disorders | Teduglutide | 1 | 8 | 1 |
| other | Headache | General disorders | Placebo | 0 | 8 | 0 |
| other | Nausea | Gastrointestinal disorders | Teduglutide | 1 | 8 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 8 | 0 |
| other | Increase in size of stoma | Gastrointestinal disorders | Teduglutide | 2 | 8 | 2 |
| other | Increase in size of stoma | Gastrointestinal disorders | Placebo | 0 | 8 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teduglutide | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Teduglutide | 2 | 8 |
| Total, other adverse events | Placebo | 1 | 8 |
| Total, serious adverse events | Teduglutide | 0 | 8 |
| Total, serious adverse events | Placebo | 0 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26223941 | RESULT |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1TR000135 | Mayo Clinic Center for Clinical and Translational Science (CCaTS) | KHOSLA, SUNDEEP | MAYO CLINIC ROCHESTER | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2012 to 2015 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Teduglutide vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02099084
GET https://conductscience.org/api/trials/v1/NCT02099084/registered