2025-524044-35-00尚未招募4 期
A Randomized, Non-inferiority Trial Comparing 7-Day Versus 4-Week Esomeprazole Treatment in Patients with Unexplained Dyspepsia
Landspitali1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2026年2月6日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change in mean daily modified Glasgow Dyspepsia Severity Score (GDSS) from Week 1 (Days 1-7) to Weeks 2-4 (Days 8-28); treatment effect is the between-arm difference in this change (non-inferiority margin 2 points).
研究概览
简要总结
To assess the difference in symptoms of dyspepsia in Glasgow Dyspepsia Severity Score (GDSS) in patients treated with PPIs for one week vs. 4 weeks.
研究设计
- 分配方式
- Randomized
- 主要目的
- A Randomized, Non-inferiority Trial Comparing 7-day Versus 4-week Esomeprazole Treatment In Patients
- 盲法
- Double (Investigator)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years at the time of enrolment
- •Unexplained dyspepsia
- •H. pylori negative
- •No PPI therapy for the last three months
- •Previous upper endoscopy normal
- •Ability to understand Icelandic or English
排除标准
- •History of upper gastrointestinal malignancy
- •Use of oral anticoagulants
- •Heart, kidney, liver and pulmonary failure
- •Active malignancy, autoimmune, neurological diseases
- •Predominant heartburn and/or acid regurgitation
- •More than minor heartburn and acid reflux on GSRS
- •Predominant symptoms of IBS
- •Known allergy to esomeprzole, Rennie and its components
- •Chronic alcohol or substance abuse (cannabis, amphetamine, cocaine), overconsumption of alcohol
- •Lactose intolerance
- •PPI use within the last 3 months
- •NSAID use 2 weeks prior to study
- •Previous upper endoscopy abnormal
- •Inability to sign informed consent
- •Inability to understand Icelandic or English
- •Eradication of H. pylori within 12 months
- •Use of biological therapy
结局指标
主要结局
Change in mean daily modified Glasgow Dyspepsia Severity Score (GDSS) from Week 1 (Days 1-7) to Weeks 2-4 (Days 8-28); treatment effect is the between-arm difference in this change (non-inferiority margin 2 points).
Change in mean daily modified Glasgow Dyspepsia Severity Score (GDSS) from Week 1 (Days 1-7) to Weeks 2-4 (Days 8-28); treatment effect is the between-arm difference in this change (non-inferiority margin 2 points).
次要结局
- The arm by time period interaction effect in a linear mixed effects model of the daily modified Glasgow Dyspepsia Score. Time period is a binary variable, the first week vs weeks 5-7.Incidence rate of referrals to upper gastrointestinal endoscopy during study weeks 1 through 7.
研究者
Investigator
Scientific
Landspitali
研究点 (1)
Loading locations...
相似试验
撤回
3 期
A randomised, controlled trial to investigate the effect of a four/six week intensified pharmacological treatment for schizophrenia, major depressive disorder and bipolar depression compared to treatment as usual in subjects who had a first-time treatment failure on their first-line treatment.2022-502185-24-00University Medical Center Utrecht945
招募中
3 期
[68Ga]Ga-PentixaFor-PET imaging for staging of marginal zone lymphoma2022-500918-25-00Pentixapharm AG148
招募中
3 期
A study comparing TAR-210 versus single agent treatment instilled directly into the bladder in people with bladder cancer with FGFR gene alterations.2023-507684-19-00Janssen Cilag International201
已完成
不适用
Radicle GI Health DBG: A Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health OutcomesNCT07318077Radicle Science750
招募中
2 期
A study in people with systemic sclerosis to test whether BI 685509 has an effect on lung function and other systemic sclerosis symptomssystemic sclerosis2022-500332-11-00Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim RCV GmbH & Co. KG68