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RECRUITING

NCT07700342

QUality of Sleep Improvement With Evening Topical Therapy for Non-Erosive Gastroesophageal Reflux Disease (The QUIET Trial)

Sponsor: Cellmedis

View on ClinicalTrials.gov

Summary

The goal of this randomized, double-blind, single-center clinical trial is to learn if medical devices work to decrease nocturnal symptoms of GERD gastroesophageal reflux disease in adults' patients and improve sleeping time, quality of sleep and quality of life of patients with nocturnal GERD symptoms. It will also teach us about safety, tolerability and improvement of patient's quality of life during and after taking medical device. The main questions it aims to answer are: * Does medical device relieve reflux symptoms during night sleep? * Does medical device improve the quality of sleep and quality of life life of patients with GERD symptoms? Researchers will compare medical device to a placebo (a look-alike substance that contains no drug) to see if medical device works in nocturnal GERD gastroesophageal reflux disease. Participants will: * Take medical device or a placebo every day just before sleeping (1 times a day) for 14 days * Visit the clinic 2 times during 14 days of this study for checkups and tests * Keep a diary of their symptoms and the number of times they use a medical device * Fill out the form to collect all necessary data. Medical device or placebo will be prepared in same looking sachets of 10 ml liquid. Medical device or placebo will be administered orally, at a dose of 10 ml one time daily just before bedtime for 14 days. The liquid should be drunk slowly, in small sips direct from the sachets.

Official title: QUality of Sleep Improvement With Evening Topical Therapy for Non-Erosive Gastroesophageal Reflux Disease: Results of a Single-center, Randomized, Double-blind, Placebo-controlled Study (The QUIET Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-09

Completion Date

2026-09-30

Last Updated

2026-07-14

Healthy Volunteers

Conditions

Nocturnal Symptoms of GERD Sleep Disorders in GERD GERD (Gastroesophageal Reflux Disease)Non-Erosive Gastro-Esophageal Reflux Disease

Interventions

DEVICE

Medical Device vs Placebo

Device: Medical Device vs Placebo Esophageal barrier medical device designed to form a bioadhesive protective barrier over gastric contents and the esophageal mucosa. The mechanism of action is local and physical, reducing exposure of the esophagus to refluxate without systemic absorption. The product is administered orally according to the study protocol and evaluated in a randomized, double blind, placebo controlled crossover design, distinguishing it from pharmacological acid suppressive therapies. Intervention Placebo oral formulation Other Names: Placebo,Matching placebo,Inactive comparator formulation Description: Oral placebo formulation designed to match the investigational product in appearance, taste, and administration schedule, without containing active components. It does not form a protective barrier and has no therapeutic effect. The placebo is administered according to the same protocol as the active intervention within a randomized, double blind,

Inclusion Criteria: 1. Diagnosis of gastroesophageal reflux disease based on the presence of typical symptoms of heartburn and/or regurgitation at least 6 months before the screening visit, confirmed by the investigator. 2. Erosive reflux disease (ERD), Barrett's esophagus, and other esophageal abnormalities confirmed by gastroscopy within the last 6 months by the investigator based on medical records. 3. Use of proton pump inhibitors in a single morning dose for at least two months prior to study entry, with an inadequate response to these medications for nocturnal symptoms of gastrointestinal reflux, and with at least moderate sleep quality disturbances, as defined by the PSQI (Pittsburgh Sleep Quality Index) score of 5-10 points - moderate sleep disturbances. 4. Not using the following medications within the month prior to the screening visit: H2 blockers, prokinetics (itopride, prucalopride), GLP1/GIP analogues, antibiotics, baclofen, tricyclic antidepressants, serotonin and/or norepinephrine reuptake inhibitors, and/or the following medications within the week prior to the screening visit: sucralfate, antacids, and esophageal protective agents. 5. Severity of gastroesophageal reflux symptoms that reduce the patient's quality of life, as subjectively confirmed by the patient. 6. Age ≥18 years of life at the time of the screening visit. 7. At the screening visit, women of childbearing potential must not be pregnant (confirmed by a urine pregnancy test) and must not be breastfeeding, or must be of non-reproductive potential (surgically sterilized, physiologically incapable of conceiving, or at least one year postmenopausal, i.e., amenorrheic for 12 consecutive months). 8. Women of childbearing potential who have a male partner of fertile potential must use a highly effective method of contraception from the screening visit until 18 weeks after the last dose of the investigational drug. 9. Men who have sex with women of childbearing potential must agree to use barrier contraceptive methods (condoms) or abstain from sexual intercourse throughout the study, beginning at the screening visit and for at least 7 days after the last dose of the investigational medical device. 10. Ability to participate in all aspects of this clinical trial. 11. A male or female patient who is able to voluntarily give informed consent. \- Exclusion Criteria: 1\. Women who have started lactation or have a positive urine test confirming pregnancy during the study enrollment visit.2. Introduction of significant changes in diet and lifestyle during the study.3. Presence of warning signs during the study enrollment visit: dysphagia or odynophagia, unintentional weight loss of more than 5% of initial weight, symptoms of gastrointestinal bleeding, anemia, upper abdominal tumor, and persistent vomiting for 7-10 days.4. Planned use during the study: antibiotics, pro-/pre-/synbiotics, short-chain fatty acids, proton pump inhibitors, H2 blockers, prokinetics (itopride, prucalopride), GLP1/GIP analogues, antibiotics, baclofen, tricyclic antidepressants, serotonin and/or norepinephrine reuptake inhibitors, and one week before the start of the study: sucralfate, antacids, and preparations protecting the esophageal mucosa.5. Diagnosis of a serious illness (e.g., cancer). 6. : Planned hospitalization for any reason or diagnosis of any serious concomitant disease which, in the opinion of the investigator, is a contraindication to participation in the study or may compromise the safety of the patient. Translated with DeepL.com (free version) 7. Current or recent (within one year prior to randomization) history of alcohol dependence or psychoactive substance abuse.8. Active psychiatric problems that, in the investigator's opinion, may interfere with compliance with study procedures.9. Presence of unstable or uncontrolled cardiovascular disorders, moderate or severe heart failure (NYHA class III or IV), any pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematopoietic, coagulation, immunological, endocrine/metabolic disorders, or other medical disorders that, in the opinion of the investigator, could affect the results of the study or compromise the safety of the patient.10. Any person who:a. Is an employee of the study site, investigator, study organization, or Sponsor.b. Is a first-degree relative of an employee of the study site, investigator, CRO, or Sponsor.c. Is unable to attend all study visits or comply with study procedures.Translated with DeepL.com (free version) \-

Locations (2)

Medical Network Sp z o.o.

Warsaw, Masovian Voivodeship, Poland