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Study · Randomized controlled trial · n = 136 · 2017

2 results

Patients With Short Bowel on Narcotics During 2 Randomized Trials Have Abdominal Complaints Independent of Teduglutide.

Fujioka K, Jeejeebhoy K, Pape UF, Li B, Youssef NN, Schneider SM

JPEN. Journal of parenteral and enteral nutrition9 Aug 2016Cited by 10 (Europe PMC)

PMID27507402 (opens in a new tab)PMCIDPMC5703028 (opens in a new tab)DOI10.1177/0148607116663481 (opens in a new tab)PepBankPUB-27507402
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Summary

BackgroundNarcotic agents are frequently administered to manage increased intestinal motility in patients with short bowel syndrome, but long-term use is associated with gastrointestinal (GI) complaints. This analysis evaluated the incidence of narcotic use and abdominal adverse events among patients with short bowel syndrome receiving teduglutide.Materials and methodsPooled data from patients who received ≥1 dose of teduglutide 0.05 mg/kg/d (n = 77) or placebo (n = 59) in either of 2 randomized, double-blind, phase III studies were analyzed.ResultsOf 136 patients, 52 (38%) received narcotics. GI adverse events occurred more often among patients who received narcotics than among those who did not (abdominal pain, 51% vs 21%; nausea, 42% vs 11%; abdominal distension, 17% vs 8%; vomiting, 19% vs 6%). Logistic regression analysis indicated that the probability of GI adverse events was significantly increased in patients with narcotic use ( P = .0009). In contrast, teduglutide treatment, as well as the interaction between teduglutide and narcotic use, did not affect the probability of GI adverse events.ConclusionsThese results suggest that patients with short bowel syndrome receiving narcotics have chronic GI complaints independent of teduglutide treatment. Data included in this analysis were derived from ClinicalTrials.gov NCT00081458 and NCT00798967 (EudraCT 2004-000438-35 and 2008-006193-15).
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In patients with short bowel syndrome, teduglutide treatment did not affect GI adverse event probability in logistic regression analysis.

    In plain wordsIn patients with short bowel syndrome, teduglutide did not change digestive adverse event probability compared with placebo in adjusted analysis.

    Peptide
    Teduglutide
    Outcome
    No significant changeGI adverse event probability
    Study

    n = 136

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.05 mg/kg/dAs given in this study (human).

    Source sentences

    Summary
    In contrast, teduglutide treatment, as well as the interaction between teduglutide and narcotic use, did not affect the probability of GI adverse events.
    2 context sentences
    Summary · context
    Logistic regression analysis indicated that the probability of GI adverse events was significantly increased in patients with narcotic use ( P = .0009).
    Summary · context
    Pooled data from patients who received ≥1 dose of teduglutide 0.05 mg/kg/d (n = 77) or placebo (n = 59) in either of 2 randomized, double-blind, phase III studies were analyzed.
  2. 02HumanObservational studySafety outcome

    In patients with short bowel syndrome, the interaction between teduglutide and narcotic use did not affect GI adverse event probability.

    In plain wordsIn patients with short bowel syndrome, the teduglutide-by-narcotic interaction did not change digestive adverse event probability.

    Peptide
    Teduglutide
    Outcome
    No significant changeTeduglutide-by-narcotic interaction for GI adverse events
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.05 mg/kg/dAs given in this study (human).

    Source sentences

    Summary
    In contrast, teduglutide treatment, as well as the interaction between teduglutide and narcotic use, did not affect the probability of GI adverse events.
    1 context sentence
    Summary · context
    Pooled data from patients who received ≥1 dose of teduglutide 0.05 mg/kg/d (n = 77) or placebo (n = 59) in either of 2 randomized, double-blind, phase III studies were analyzed.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00798967

Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects

Shiren = 8625 Nov 2008 to 25 Jan 2011

Short Bowel Syndrome

Trial pageClinicalTrials.govUpdated 3 Jun 2021
CompletedPhase 3Results postedNCT00081458

Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome

Shiren = 8425 May 2004 to 6 Jul 2007

Short Bowel Syndrome

Trial pageClinicalTrials.govUpdated 9 Jun 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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