Evidence map›Paper›PMID 29788903›Full record

Trial reportBMC gastroenterology2018

Sustained efficacy following resolution of frequent heartburn with an over-the-counter regimen of esomeprazole 20 mg or placebo for 14 days: two randomized trials.

David A Peura, Anne Le Moigne, Heather Wassel, Charles Pollack

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in BMC gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 39% of its field
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.

NCT01370525 phase3completednot on this map

A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn

TypeinterventionalSponsorAstraZenecaRan2011 to 2011Enrolled340ConditionsHeartburnArmsEsomeprazole
NCT01370538 phase3completednot on this map

A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn

TypeinterventionalSponsorAstraZenecaRan2011 to 2011Enrolled341ConditionsHeartburnArmsEsomeprazole
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. 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

4 authors at 2 institutions in 1 country.

David A PeuraUniversity of Virginia, School of Medicine, Charlottesville, VA, 22908, USA. DAP8V@hscmail.mcc.virginia.edu.
Anne Le MoigneClinical Excellence and Biometrics, Pfizer Consumer Healthcare, Madison, NJ, 07940, USA.
Heather WasselPfizer Consumer Healthcare, Madison, NJ, USA.
Charles PollackFormer Senior Director, Global R&D, Pfizer Consumer Healthcare, Madison, NJ, 07940, USA.
Pfizer (United States) · USUniversity of Virginia · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA two-week course of therapy with an over-the-counter proton-pump inhibitor (PPI) is recommended for frequent heartburn. Limited research has been conducted on the sustained efficacy of short-term PPI therapy after treatment cessation. Esomeprazole 20 mg was evaluated in the seven-day follow-up period after the two-week treatment period using pooled data from two identical randomized, double-blind, placebo-controlled studies.

methodsAdults without confirmed diagnoses of gastroesophageal reflux disease experiencing heartburn at least two days/week in the past four weeks were eligible. Subjects received treatment with esomeprazole 20 mg or placebo once daily for 14 days. Heartburn episodes were documented using daily diaries. Missing data during the two-week treatment period were assumed to be days with heartburn. The proportion of subjects with heartburn resolution while on treatment and during the seven days of follow-up was assessed. Predictors of resolution during this post-treatment period were evaluated using a stepwise logistic regression model.

resultsAll subjects in the pooled analysis set who reported diary data for at least three follow-up days were analyzed (N = 584). This cut-off was used to ensure that sufficient data were collected for these analyses. Greater run-in heartburn frequency was a significant negative predictor of heartburn resolution during follow-up (P < 0.001). Among the on-treatment efficacy variables, the best predictor of resolution during follow-up was resolution during the last seven days of treatment (odds ratio: 3.81 [95% confidence interval: 2.40, 6.05; P < 0.0001]).

conclusionsLower baseline heartburn frequency and heartburn resolution during the last seven days of treatment were associated with a greater likelihood of heartburn resolution during the seven-day follow-up.

trial registrationRegistered at ClinicalTrials.gov June 11, 2011: NCT01370525 ; NCT01370538 .

Indexed as

AdultDouble-Blind MethodDrug Administration ScheduleEsomeprazoleFemaleFollow-Up StudiesHeartburnHumansMaleMiddle AgedNonprescription DrugsProton Pump InhibitorsTreatment OutcomeEsomeprazoleNonprescription DrugsProton Pump InhibitorsEsomeprazoleGastric acid/secretionHeartburnProton pump inhibitor

Identifiers

PMID29788903
PMCPMC5964662
OpenAlexW2807592841

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.