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临床试验/NCT03319121
NCT03319121已完成2 期

The Evaluation of Effectiveness Between Empirical and Guided Therapy for Unexplained Non-Cardiac Chest Pain

Universiti Sains Malaysia1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
68
试验地点
1
主要终点
Non-cardiac chest pain symptoms assessed by visual analog scale (VAS)

研究概览

简要总结

This is a prospective randomised clinical trial performed in a single center at Hospital Universiti Sains Malaysia (USM), Kelantan, Malaysia. Participants will be randomly allocated into either the empirical group or guided group for 8 weeks.The effectiveness in relieving chest pain (frequency and severity) will assessed after 2 weeks and 8 weeks of therapy with Gastroesophageal Reflux Disease Questionnaire (GERDQ) and Quality of Life Reflux and Dyspepsia (QOLRAD) questionnaire, and visual analogue scale (VAS) (score 1-10).

详细描述

Non-cardiac chest pain (NCCP) is very common in the general population but symptom alone or patient's characteristics do not adequately differentiate cardiac and esophageal cause. Cardiologists are usually consulted first to exclude life-threatening acute coronary syndrome. Tests that are performed to exclude ischemic heart disease include exercise stress test and the more invasive coronary angiography. A negative stress test or angiogram or the presence of mild blockage of a single vessel disease will usually be adequate to exclude significant ischemia as a cause for chest pain.

The next most important cause of unexplained chest pain would be gastro-esophageal reflux disease (GERD). GERD and its complications of Barrett's oesophagus and oesophageal adenocarcinoma have increased markedly in recent decades, not just in the developed countries but also in Asia. Although relatively less common among populations in Malaysia, there are data to suggest an increasing prevalence of reflux disease largely a result of obesity and increased intra-abdominal pressure.

Dexlansoprazole (Takeda Pharmaceuticals, Japan) is a novel dual delayed release system recently approved by the FDA for treatment of heartburn associated with non-erosive and erosive reflux disease. It is unknown if dexlansoprazole is effective as an empirical therapy for NCCP.

Another approach would be therapy guided by investigations including high resolution (HR) esophageal impedance manometry and 24-hour pH-impedance studies. Study of esophageal function has greatly evolved with the recent availability of high resolution multi-channel solid state manometer and impedance. Water swallows are commonly used in esophageal manometric studies to evaluate for peristaltic abnormalities. Esophageal pH monitoring does not detect all gastroesophageal reflux (GER) events but with the combination of impedance, this technique allows detection of GER of gas and acid or non-acid liquids. These tests would enable diagnosis of GERD and functional chest pain and thereby allow targeted therapy.

For treatment of GERD, dexlansoprazole is effective and for functional chest pain, nonspecific adenosine antagonist, theophylline is proven to improve symptoms in patient with hypersensitive esophagus. A selective serotonin reuptake inhibitor (SSRI) is also effective for functional chest pain , however it is not known if theophylline is more effective than any other SSRIs.It is unknown about the response rates based on the guided therapy approach compared to the empirical PPI therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

No masking

入排标准

年龄范围
18 Months 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants with chest pain but normal angiogram or a negative stress test or normal electrocardiogram and cardiac enzyme.

排除标准

  • Participants with any medications that might affect the upper GI tract, previous surgeries of the upper GI tract and a negative endoscopic examination for peptic ulcer disease and upper GI tract malignancies
  • Participants with chronic, debilitating or life-threatening medical conditions and presence of overt psychiatric or psychological disturbances.

研究组 & 干预措施

Empirical therapy group

Experimental

Participants will be given extended release lansoprazole (Dexlansoprazole, Takeda Pharmaceuticals, Japan) 60 mg daily for 2 weeks

干预措施: Empirical therapy group (Drug)

Guided therapy group

Experimental

Participants will be give Dexlansoprazole 30 mg daily for GERD, 60 mg daily for GERD with erosive esophagitis for 8 weeks and Theophylline SR 250 mg daily for functional chest pain for 4 weeks.

干预措施: Guided therapy group (Drug)

结局指标

主要结局

Non-cardiac chest pain symptoms assessed by visual analog scale (VAS)

时间窗: 8 weeks

Visual analog scale (VAS) was used to assess the non-cardiac chest pain symptoms. VAS is a psychometric response scale. The scale has scores from 0 to 10 with 1 cm interval between scores and with 0 denotes no pain, 5 denote moderate pain and 10 denote the worst possible pain.

次要结局

  • Non-cardiac chest pain symptoms assessed by gastroesophageal reflux disease questionnaire (GERDQ)(8 weeks)
  • Non-cardiac chest pain symptoms assessed by quality of life in reflux and dyspepsia questionnaire (QOLRAD)(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeong Yeh Lee

Professor Dr

Universiti Sains Malaysia

研究点 (1)

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