Effect of Lemborexant on Reflux Symptoms

Effect of Lemborexant in Patients with Gastroesophageal Reflux Disease - Effect of Lemborexant in GERD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031210155

Enrollment

Registered

2021-06-17

Start date

2021-06-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal reflux diseases and insomia

Interventions

Taking lemborexant 5mg at bedtime for 28 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.205 in Pittsburgh sleep quality index (PSQI) and total score >=8 in GerdQ questionnaire.

Exclusion criteria

Exclusion criteria: 1.Endoscopic esophagitis Los Angeles Classification grades C or D 2.3 cm or more hiatus hernia 3.Scleroderma 4.Taking hypnotics, antidepressants, antipsychotics, anticholinergics, prokinetics, histamine H2 channel blockers, proton pump inhibitors, vonoprazan within 4 weeks prior to the study 5.Active psychological disorders 6.Shift worker 7.History of Upper gastrointestinal surgeries 8.Diabetes 9.Sleep apnea syndrome 10.Pregnant women, women planning on becoming pregnant during the study, lactating 11.Heart diseases and cancers 12.Significant liver/kidney diseases 13.Central nervous system disease, cognitive impairment 14.Allergies to xylocaine or lemborexant 15.narcolepsy. catalepsy 16.respiratory disorders 17.alcoholic 18.achalasia on high resolution manometry

Design outcomes

Primary

Measure	Time frame
Changes in GerdQ score after the intervention. The question of GerdQ about sleep disturbance due to nighttime heartburn or regurgitation is excluded in the analysis for the primary outcome.	—

Secondary

Measure	Time frame
-parameters on 24h reflux study: Esophageal acid exposure time%, number of reflux episodes, number of acid reflux episodes, number of non-acid reflux episodes, bolus exposure time, acid clearance time, number of symptoms, symptom index, symptom association probability. -Total score in PSQI -Score of each question in GerdQ and changes in GerdQ score during taking lemborexant. -Correlation between GerdQ scores and PSQI scores -Predictive markers for effectiveness of lemborexant in patients with reflux symptoms - Changes in F-scale total score after the intervention	—

Measure

Time frame

-parameters on 24h reflux study: Esophageal acid exposure time%, number of reflux episodes, number of acid reflux episodes, number of non-acid reflux episodes, bolus exposure time, acid clearance time, number of symptoms, symptom index, symptom association probability. -Total score in PSQI -Score of each question in GerdQ and changes in GerdQ score during taking lemborexant. -Correlation between GerdQ scores and PSQI scores -Predictive markers for effectiveness of lemborexant in patients with reflux symptoms - Changes in F-scale total score after the intervention

—

Contacts

Public ContactHoshikawa Yoshimasa

Nippon Medical School Hospital

y-hoshikawa@nms.ac.jp+81-3-3822-2131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026