Responder
| Group | Value (subjects) |
|---|---|
| Teduglutide | 27 |
| Placebo | 13 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name STEPS
United States, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.
Experimental
Teduglutide
0.05 mg/kg/day sc dose of teduglutide
Placebo comparator
Placebo
Matching subcutaneous dose of placebo to teduglutide
Outcomes the sponsor listed as primary.
Responder
Time frame · Weeks 20 and 24
Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24.
Absolute Change in PN/I.V. Volume From Baseline to Last Time Point
Time frame · Week 0 to last visit when data was collected.
Absolute change in the volume of PN/I.V. from baseline (Week 0) to the visit when the last data point was collected (week 4 through week 24, or earlier if the subject discontinued early).
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (subjects) |
|---|---|
| Teduglutide | 27 |
| Placebo | 13 |
| Group | Value (Liters/Week) | Spread |
|---|---|---|
| Teduglutide | -4.28 | 3.81 |
| Placebo | -2.38 | 2.79 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Teduglutide0.05 mg/kg/day subcutaneous (sc) dose of teduglutide | – | 15 / 42 | 35 / 42 |
| PlaceboMatching sc dose of placebo to teduglutide | – | 12 / 43 | 34 / 43 |
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
Studies that cite this trial.
5 studies on this page
Indexing hint: Randomized controlled trial · 2020
Jeppesen et al. 2020Clinical nutrition (Edinburgh, Scotland)cited by 18
PMID 31784300DOI 10.1016/j.clnu.2019.11.001PUB-31784300
Indexing hint: Randomized controlled trial · 2018
Jeppesen et al. 2018Gastroenterologycited by 102
PMID 29174926DOI 10.1053/j.gastro.2017.11.023PUB-29174926
Indexing hint: Randomized controlled trial · 2017
Fujioka et al. 2017JPEN. Journal of parenteral and enteral nutritioncited by 10
PMID 27507402PMC5703028DOI 10.1177/0148607116663481PUB-27507402
Indexing hint: Randomized controlled trial · 2013
Jeppesen et al. 2013Clinical nutrition (Edinburgh, Scotland)cited by 79
PMID 23587733DOI 10.1016/j.clnu.2013.03.016PUB-23587733
Indexing hint: Randomized controlled trial · 2012
Jeppesen et al. 2012Gastroenterologycited by 348
PMID 22982184DOI 10.1053/j.gastro.2012.09.007PUB-22982184
1 study on this page
Indexing hint: Clinical trial · 2005
Jeppesen et al. 2005Gutcited by 353
PMID 16099790PMC1774653DOI 10.1136/gut.2004.061440PUB-16099790
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated