Trial · NCT03408132
Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency
NCT03408132, Phase 1, Phase 2, Completed, GlyPharma Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency. Trials, record NCT03408132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03408132
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency
- NCT number
- NCT03408132
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- GlyPharma Therapeutics
- Conditions
- SBS - Short Bowel Syndrome
- Interventions
- FE203799
- First posted
- 2018-01-23
- Last updated
- 2024-10-24
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of treatment-emergent adverse events | Day -28 to Day 26 plus 6 weeks | Adverse events as assessed by CTCAE v4.03 |
| Secondary | Assessment of intestinal insufficiency and gut absorption | Day -28 to day 26 | Changes in the wet weight (g) of faecal excretion |
| Secondary | Assessment of intestinal insufficiency and gut absorption | Day -28 and day 26 | Changes from baseline in lean body mass by DEXA scan. |
| Secondary | Assessment of intestinal insufficiency and gut absorption | Day -28 and day 26 | Changes from baseline in bone mineral content by DEXA scan. |
| Secondary | Assessment of intestinal insufficiency and gut absorption | Day -28 and day 26 | Changes from baseline in fat mass by DEXA scan. |
| Secondary | Assessment of intestinal insufficiency and gut absorption | Day -28 to day 26 plus 6 weeks | Measure of body weight (kg) |
| Secondary | Assessment of intestinal insufficiency and gut absorption | Baseline (Day -6) to end of treatment (Day 26) | Measurement of urinary output (ml) |
| Secondary | Assessment of intestinal insufficiency and gut absorption | Baseline (Day -6) to end of treatment (Day 26) | Measurement of urinary electrolytes (sodium, potassium, calcium, magnesium) (mmol/d) |
| Secondary | Assessment of gut regeneration | Baseline (Day -7) to end of treatment period (Day 26) plus 6 weeks | Measurements of the plasma Citrulline (ng/ml) |
| Secondary | Maximum observed plasma concentration (Cmax) | Day 1 to end of treatment period (Day 26) | Cmax (ng/ml) |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03408132
GET https://conductscience.org/api/trials/v1/NCT03408132/registered