Evidence map›Paper›PMID 19691492›Full record

Trial reportNeurogastroenterology and motility2010

Effects of Velusetrag (TD-5108) on gastrointestinal transit and bowel function in health and pharmacokinetics in health and constipation.

M L Manini, M Camilleri, M Goldberg, S Sweetser, S McKinzie, D Burton, S Wong, M M Kitt, Y-P Li, A R Zinsmeister

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Neurogastroenterology and motility, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing 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

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Nausea and Vomiting in 2021: A Comprehensive Update.Journal of clinical gastroenterology · 2021
    Review
  5. Review
  6. Diabetic Gastroparesis.Endocrine reviews · 2019
    Review
  7. Endoscopic Therapies for Gastroparesis.Current gastroenterology reports · 2018
    Review
  8. Review
  9. Review
  10. Review
  11. Gastroparesis: Medical and Therapeutic Advances.Digestive diseases and sciences · 2017
    Review
  12. Review
  13. Newest Drugs for Chronic Unexplained Nausea and Vomiting.Current treatment options in gastroenterology · 2016
    Review
  14. Article
  15. Novel Diet, Drugs, and Gastric Interventions for Gastroparesis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2016
    Review
  16. Review
  17. Current and Emerging Medical Therapies for Gastroparesis.Current treatment options in gastroenterology · 2015
    Article
  18. Prokinetics in the Management of Functional Gastrointestinal Disorders.Journal of neurogastroenterology and motility · 2015
    Article
  19. Review
  20. 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

10 authors.

M L ManiniClinical Enteric Neuroscience Translational and Epidemiological Research, College of Medicine, Mayo Clinic, Rochester, MN 55905, USA.
M Camilleri
M Goldberg
S Sweetser
S McKinzie
D Burton
S Wong
M M Kitt
Y-P Li
A R Zinsmeister

Funding

MAYO CLINIC CENTER FOR TRANSLATIONAL SCIENCE ACTIVITIESUL1RR024150 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 2006 to 2011
$66.4M
ALPHA 2 ADRENERGIC CONTROL IN IRRITABLE BOWEL SYNDROMEK24DK002638 · NIDDK · MAYO CLINIC ROCHESTER · PI CAMILLERI, MICHAEL L. · 1999 to 2008
$1.1M
NCRR NIH HHS RR0024150NCRR NIH HHS UL1 RR024150NIDDK NIH HHS K24 DK002638NIDDK NIH HHS K24-DK02638
6 · The paper itself

Abstract

Velusetrag (TD-5108) is a potent, selective high intrinsic activity serotonin 5-HT(4) receptor agonist. We assessed effects of Velusetrag on gastrointestinal transit and compared its pharmacokinetics in healthy volunteers (HV) and chronic constipation (CC) patients. Sixty HV were randomly assigned, double-blind to placebo, 5, 15, 30 or 50 mg Velusetrag (single and 6-day dosing). Primary endpoints were colonic transit (geometric centre at 24 h, GC24) and ascending colon emptying (ACE) T(1/2) after first dose. Secondary endpoints included gastric emptying (GE) T(1/2) and colonic filling at 6 h (CF6). Single dose Velusetrag significantly accelerated GC24, ACE T(1/2), and CF6; 30 and 50 mg Velusetrag accelerated all three endpoints. With multiple doses, Velusetrag 30 mg accelerated GC24, and overall accelerated GE T(1/2) at 15-50 mg. Pharmacokinetics studies showed dose proportionality in health, and no significant differences between health and chronic constipation with a 15 mg oral dose of Velusetrag. Stimulation of bowel function after15 mg Velusetrag was similar in CC and controls. There were no serious adverse events; notable adverse events were the predictable gastrointestinal effects such as diarrhoea or altered bowel movements. Velusetrag significantly accelerated intestinal and colonic transit after single dosing and accelerated gastric emptying after multiple dosing. Further studies of its potential as a gastrointestinal and colonic prokinetic are warranted.

Indexed as

Azabicyclo CompoundsGastrointestinal AgentsAdolescentAdultAgedConstipationDose-Response Relationship, DrugDouble-Blind MethodFemaleGastrointestinal MotilityGastrointestinal TransitHumansIntestinesMaleMiddle AgedPlacebosAzabicyclo CompoundsGastrointestinal AgentsPlacebosTD-5108

Identifiers

PMID19691492
PMCPMC2905526

What OpenQuestion holds

Textmetadata
LicenceTDM
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.