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New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease (The RELIEF Trial) (RELIEF)

2026년 7월 9일 업데이트: Cellmedis

New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease: rEsults oF a Single-center, Randomized, Double-blind, Placebo-controlled Crossover Trial. (The RELIEF Trial)

The goal of this randomized, double-blind, single-center clinical trial RELEIF is to learn if medical devices work to decrease symptoms of gastroesophageal reflux disease (GERD) in adults' patients. 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?
  • Does medical device improve the quality of 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 GERD gastroesophageal reflux disease .

Participants will:

  • Take medical device or a placebo every day (4 times a day) for 14 days
  • Stop taking medical device or placebo for 7 days (wash out period)
  • Switch the therapy for medical device or placebo for next 14 days
  • Visit the clinic 4 times during 35 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This medical device was developed as a modern therapeutic alternative, offering rapid symptom relief and long-term protective effects on the esophageal mucosa. The introduction of medical device aims to expand the available therapeutic options for patients suffering from GERD symptoms and to support physicians in selecting optimal therapy. Thanks to its innovative formula, medical device can avoid the rising the symptoms, provide improved well-being and reduce the frequency of acute medication use.

연구 유형

중재적

등록 (추정된)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 폴란드
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, 폴란드, 04-501
        • 모병
        • Medical Network
        • 연락하다:
        • 연락하다:
        • 부수사관:
          • Konrad Lewandowski, MD, PhD
        • 수석 연구원:
          • Grażyna Rydzewska - Wyszkowska, Prof., MD, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Diagnosis of gastroesophageal reflux disease based on the presence of typical symptoms such as heartburn and or regurgitation for at least 6 months prior to the screening visit, confirmed by the investigator
  • Exclusion of erosive reflux disease, Barrett esophagus, and other esophageal abnormalities by upper gastrointestinal endoscopy within the last 6 months, confirmed by the investigator based on medical documentation
  • No use within 1 month prior to screening of proton pump inhibitors, H2 receptor antagonists, prokinetics such as itopride or prucalopride, GLP1 or GIP analogues, antibiotics, baclofen, tricyclic antidepressants, serotonin and or noradrenaline reuptake inhibitors, and no use within 1 week prior to screening of sucralfate, antacids, or esophageal mucosal protective agents
  • Presence of gastroesophageal reflux symptoms that negatively impact quality of life, as subjectively reported by the patient and confirmed by the investigator
  • Age 18 years or older at the time of screening
  • Women of childbearing potential must not be pregnant confirmed by a negative urine pregnancy test and must not be breastfeeding, or must be of non childbearing potential defined as surgically sterile, physiologically incapable of becoming pregnant, or at least 12 months post menopause
  • Women of childbearing potential with a male partner of reproductive potential must use a highly effective method of contraception from screening until 18 weeks after the last dose of the investigational medical device
  • Sexually active men with women of childbearing potential must agree to use barrier contraception such as condoms or abstain from sexual intercourse throughout the study period and for at least 7 days after the last dose of the investigational medical device
  • Ability to comply with all aspects of the clinical study
  • Male patients eligible for participation in the study.

Exclusion Criteria:

  • Women who are breastfeeding or have a positive urine pregnancy test at the baseline visit
  • Introduction of significant changes in diet or lifestyle during the study period
  • Presence of alarm symptoms at baseline including dysphagia or odynophagia, unintentional weight loss greater than 5 percent of baseline body weight, signs of gastrointestinal bleeding, anemia, palpable epigastric mass, or persistent vomiting lasting 7 to 10 days
  • Planned use during the study of antibiotics, probiotics, prebiotics, synbiotics, short chain fatty acids, proton pump inhibitors, H2 receptor antagonists, prokinetics such as itopride or prucalopride, GLP1 or GIP analogues, baclofen, tricyclic antidepressants, serotonin and or noradrenaline reuptake inhibitors, and use within 1 week prior to study start of sucralfate, antacids, or esophageal mucosal protective agents
  • Diagnosis of a severe disease such as malignancy
  • Planned hospitalization for any reason or presence of any severe comorbidity that in the opinion of the investigator constitutes a contraindication to study participation or may compromise patient safety
  • Current or recent history within 1 year prior to randomization of alcohol dependence or substance abuse
  • Active psychiatric disorders that in the opinion of the investigator may interfere with compliance with study procedures
  • Presence of unstable or uncontrolled cardiovascular disorders, moderate or severe heart failure classified as New York Heart Association class III or IV, or any clinically significant pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine or metabolic disorder, or any other medical condition that in the opinion of the investigator could affect study results or patient safety
  • Individuals who are employees of the study site, investigator, contract research organization, or sponsor
  • First degree relatives of employees of the study site, investigator, contract research organization, or sponsor
  • Individuals unable to attend all study visits or comply with study procedures.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Placebo Followed by Esophageal Barrier Medical Device Arm
Participants receive Placebo oral formulation during the first treatment period followed by esophageal barrier medical device during the second treatment period with a washout interval.
장치: Esophageal barrier medical device
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.
장치: Placebo oral formulation
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, placebo controlled crossover design to ensure blinding and allow comparative assessment.
다른 이름들:
  • 위약
  • 일치하는 위약
  • Inactive comparator formulation
실험적: Esophageal Barrier Medical Device Followed by Placebo Arm
Participants receive esophageal barrier medical device during the first treatment period followed by Placebo oral formulation during the second treatment period with a washout interval.
장치: Esophageal barrier medical device
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.
장치: Placebo oral formulation
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, placebo controlled crossover design to ensure blinding and allow comparative assessment.
다른 이름들:
  • 위약
  • 일치하는 위약
  • Inactive comparator formulation

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in reflux symptom severity score
기간: Baseline and after 14 days of treatment in each treatment period of the crossover study.
Change from baseline in patient reported gastroesophageal reflux symptoms assessed using the GERD-HRQL questionnaire. Clinical response is defined as a reduction of at least 50 percent in the total GERD-HRQL score after 14 days of treatment with esophageal barrier medical device compared with placebo.
Baseline and after 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with complete clinical remission
기간: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients achieving complete clinical remission of gastroesophageal reflux symptoms assessed using the GERD-HRQL questionnaire. Complete remission is defined as a total score of 0 points in questions 1 to 15 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
After 14 days of treatment in each treatment period of the crossover study.

2차 결과 측정

결과 측정
측정값 설명
기간
Onset and duration of action of the investigational device.
기간: During the 14 day treatment period, assessed after each administration throughout each treatment phase.
Assessment of the onset and duration of action of the esophageal barrier medical device using a patient reported questionnaire. Onset of action is defined as the subjective relief of heartburn within two predefined time intervals: up to 15 minutes classified as very rapid onset and 16 to 30 minutes classified as rapid onset. Duration of action is defined as the time period free from reflux symptoms following administration of the investigational product.
During the 14 day treatment period, assessed after each administration throughout each treatment phase.
Proportion of patients with complete clinical remission of heartburn.
기간: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients achieving complete clinical remission of heartburn assessed using the GERD-HRQL questionnaire. Complete remission of heartburn is defined as a total score of 0 points in questions 1 to 6 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with clinical response of heartburn.
기간: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients achieving clinical response of heartburn assessed using the GERD-HRQL questionnaire. Clinical response is defined as a reduction of at least 50 percent in the total score of questions 1 to 6 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with complete clinical remission of regurgitation.
기간: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients achieving complete clinical remission of regurgitation assessed using the GERD-HRQL questionnaire. Complete remission of regurgitation is defined as a total score of 0 points in questions 10 to 15 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with clinical response of regurgitation.
기간: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients achieving clinical response of regurgitation assessed using the GERD-HRQL questionnaire. Clinical response is defined as a reduction of at least 50 percent in the total score of questions 10 to 15 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
After 14 days of treatment in each treatment period of the crossover study.
Change in heartburn and regurgitation severity on Likert scale
기간: Baseline and after 14 days of treatment in each treatment period of the crossover study.
Change in severity of heartburn and regurgitation assessed using a five point Likert scale. Improvement is defined as a reduction of at least 2 points in the combined symptom severity score after 14 days of treatment with esophageal barrier medical device compared with placebo.
Baseline and after 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with improvement in quality of life
기간: Baseline and after 14 days of treatment in each treatment period of the crossover study.
Proportion of patients achieving improvement in quality of life assessed using the 36 Item Short Form Survey SF 36. Improvement is defined as a reduction of at least 5 points in the total SF 36 score after 14 days of treatment with esophageal barrier medical device compared with placebo.
Baseline and after 14 days of treatment in each treatment period of the crossover study.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Cellmedis

협력자

Medical Network Sp. z o.o.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 28일

기본 완료 (추정된)

2026년 9월 30일

연구 완료 (추정된)

2026년 9월 30일

연구 등록 날짜

최초 제출

2026년 5월 28일

QC 기준을 충족하는 최초 제출

2026년 5월 28일

처음 게시됨 (실제)

2026년 6월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 9일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • AZ001-01-01 (RELIEF Trial)
  • CIV-PL-26-03-057013 (기타 식별자: EUDAMED)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be made publicly available due to privacy considerations and applicable data protection regulations. Aggregated and anonymized results will be reported in scientific publications. Data may be available from the corresponding author upon reasonable request, subject to institutional approval and data sharing agreements.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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