Evidence map›Paper›PMID 28916953›Full record

Trial reportDigestive diseases and sciences2017

Dexlansoprazole for Heartburn Relief in Adolescents with Symptomatic, Nonerosive Gastro-esophageal Reflux Disease.

Benjamin D Gold, Betsy Pilmer, Jaroslaw Kierkuś, Barbara Hunt, Maria Claudia Perez, David Gremse

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01642602 (A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent Subjects Aged 12 to 17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 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.

NCT01642602 phase2completednot on this map

A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent Subjects Aged 12 to 17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

TypeinterventionalSponsorTakedaRan2012 to 2014Enrolled104ConditionsGastroesophageal Reflux DiseaseArmsDexlansoprazole
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. The Spectrum of Reflux Phenotypes.Gastroenterology & hepatology · 2019
    Article
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

6 authors.

Benjamin D GoldChildren's Center for Digestive Healthcare, LLC, 993D Johnson Ferry Rd. NE, Suite 440, Atlanta, GA, 30342, USA. bgold@gicareforkids.com.
Betsy PilmerTakeda Development Center Americas, Inc, One Takeda Parkway, Deerfield, IL, 60015, USA.
Jaroslaw KierkuśDepartment of Gastroenterology, Hepatology, Feeding Disorders and Paediatrics, The Children's Memorial Health Institute, Al. Dzieci Polskich 20, 04-730, Warsaw, Poland.
Barbara HuntTakeda Development Center Americas, Inc, One Takeda Parkway, Deerfield, IL, 60015, USA.
Maria Claudia PerezTakeda Development Center Americas, Inc, One Takeda Parkway, Deerfield, IL, 60015, USA.
David GremseDepartment of Pediatrics, College of Medicine, University of South Alabama, 1601 Center Street, Suite 1271, Mobile, AL, 36604, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProton pump inhibitors are commonly used to treat gastro-esophageal reflux disease (GERD) and nonerosive GERD (NERD) in adolescents and adults. Despite the efficacy of available medications, many patients have persisting symptoms, indicating a need for more effective agents.

aimsTo assess the safety and efficacy of dexlansoprazole dual delayed-release capsules in adolescents for treatment of symptomatic NERD.

methodsA phase 2, open-label, multicenter study was conducted in adolescents aged 12-17 years. After a 21-day screening period, adolescents with endoscopically confirmed NERD received a daily dose of 30-mg dexlansoprazole for 4 weeks. The primary endpoint was treatment-emergent adverse events (TEAEs) experienced by ≥5% of patients. The secondary endpoint was the percentage of days with neither daytime nor nighttime heartburn. Heartburn symptoms and severity were recorded daily in patient electronic diaries and independently assessed by the investigator, along with patient-reported quality of life, at the beginning and end of the study.

resultsDiarrhea and headache were the only TEAEs reported by ≥5% of patients. Dexlansoprazole-treated patients (N = 104) reported a median 47.3% of days with neither daytime nor nighttime heartburn. Symptoms such as epigastric pain, acid regurgitation, and heartburn improved in severity for 73-80% of patients. Pediatric Gastroesophageal Symptom and Quality of Life Questionnaire-Adolescents-Short Form symptom and impact subscale scores (scaled 1-5) each decreased by an average of 0.7 units at week 4.

conclusionsUse of 30-mg dexlansoprazole in adolescent NERD was generally well tolerated and had beneficial effects on improving heartburn symptoms and quality of life.

trial registrationThis study has the ClinicalTrials.gov identifier NCT01642602.

Indexed as

Administration, OralAdolescentAge of OnsetCapsulesChildDelayed-Action PreparationsDexlansoprazoleEuropeFemaleGastroesophageal RefluxHeartburnHumansLatin AmericaMaleNorth AmericaProton Pump InhibitorsCapsulesDelayed-Action PreparationsDexlansoprazoleProton Pump InhibitorsAdolescentGERDHeartburnNERDNonerosivePPI

Identifiers

PMID28916953
PMCPMC5649596

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Registered trials

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.