Evidence map›Paper›PMID 29959787›Full record

Trial reportBritish journal of clinical pharmacology2018

Effect of single and multiple doses of elobixibat, an ileal bile acid transporter inhibitor, on chronic constipation: A randomized controlled trial.

Yuji Kumagai, Hideki Amano, Yoshinobu Sasaki, Chie Nakagawa, Mika Maeda, Ichiro Oikawa, Hidetoshi Furuie

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. Review
  4. Ileal bile acid transporter inhibitors for chronic constipation in the elderly.World journal of gastrointestinal pharmacology and therapeutics · 2026
    Article
  5. Article
  6. Article
  7. Article
  8. Bile acids and microbes in metabolic disease.World journal of gastroenterology · 2022
    Review
  9. Article
  10. Review
  11. Observational
  12. Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Observational
  19. Article
  20. What's in the pipeline for lower functional gastrointestinal disorders in the next 5 years?American journal of physiology. Gastrointestinal and liver physiology · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Yuji KumagaiKitasato University East Hospital, Kanagawa, Japan.
Hideki AmanoDepartment of Pharmacology, Kitasato University School of Medicine, Kanagawa, Japan.
Yoshinobu SasakiKitasato University East Hospital, Kanagawa, Japan.
Chie NakagawaKitasato University East Hospital, Kanagawa, Japan.
Mika MaedaKitasato University East Hospital, Kanagawa, Japan.
Ichiro OikawaClinical Development Department, EA Pharma Co., Ltd., Tokyo, Japan.ORCID 0000-0001-8628-2843
Hidetoshi FuruieOPHAC Hospital, Osaka, Japan.ORCID 0000-0002-8256-0516

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsElobixibat is a minimally absorbed ileal bile acid transporter inhibitor. This study aimed to investigate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of elobixibat in Japanese patients with chronic constipation.

methodsThis study consisted of single-dose and multiple-dose tests with a dose-escalating design. Sixty patients including females and males were randomized into five dose levels of elobixibat (2.5, 5, 10, 15 or 20 mg, n = 10 per level) and corresponding placebo (n = 2 per group). A crossover design was used to examine food effect in single-dose test. Patients received test tablets once daily for 14 days in multiple-dose test. We assessed pharmacokinetic-dose proportionality, levels of serum high- and low-density lipoprotein cholesterol and plasma 7α-hydroxy-4-cholesten-3-one (C4), food effect and sex-specific effect. Adverse events and bowel functions such as bowel movements, stool consistency and straining were also evaluated.

resultsFood consumption reduced systemic exposure by around 80% [e.g. least squares mean (ratio of breakfast/no breakfast) maximum plasma concentration: 0.2085 (90% confidence interval, 0.1371-0.3172) at 15 mg] while increased plasma C4 level (P < 0.001). In the multiple-dose test, elobixibat reduced low-density lipoprotein cholesterol and increased C4 whilst unaltering high-density lipoprotein cholesterol level. The increased spontaneous bowel movement frequency was correlated with higher dosage and higher C4 level (R

conclusionsElobixibat should be taken before breakfast. Once-daily administration of elobixibat was found to be safe and tolerated up to 20 mg in female and male patients with chronic constipation.

Indexed as

Administration, OralAdultCarrier ProteinsCholestenonesCholesterol, LDLChronic DiseaseConstipationCross-Over StudiesDefecationDipeptidesDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFood-Drug InteractionsHumans7 alpha-hydroxy-4-cholesten-3-onebile acid binding proteinsCarrier ProteinsCholestenonesCholesterol, LDLDipeptideselobixibatMembrane GlycoproteinsPlacebosTabletsThiazepinesgastroenterologypharmacodynamicspharmacokineticsphase Irandomized controlled trial

Identifiers

PMID29959787
PMCPMC6138487

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.