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

NCT ID: NCT03319121

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-12-31

Brief Summary

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).

Detailed Description

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.

Therefore, the aim of the intervention is to evaluate the effectiveness of empirical therapy vs. guided therapy on symptoms unexplained non-cardiac chest pain.

Conditions

Non Cardiac Chest Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Empirical therapy group

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

Group Type: EXPERIMENTAL

Empirical therapy group

Intervention Type: DRUG

Receive extended release lansoprazole (Dexlansoprazole, Takeda Pharmaceuticals, Japan) 60 mg daily for 2 weeks.

Guided therapy group

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.

Group Type: EXPERIMENTAL

Guided therapy group

Intervention Type: DRUG

Receive 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.

Interventions

Empirical therapy group

Receive extended release lansoprazole (Dexlansoprazole, Takeda Pharmaceuticals, Japan) 60 mg daily for 2 weeks.

Intervention Type: DRUG

Guided therapy group

Receive 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.

Intervention Type: DRUG

Other Intervention Names

Dexlansoprazole; Dexlansoprazole and/or Theophylline SR

Eligibility Criteria

Exclusion Criteria

1. 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

2. Participants with chronic, debilitating or life-threatening medical conditions and presence of overt psychiatric or psychological disturbances.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Yeong Yeh Lee

Professor Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yeong Yeh Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

Locations

Hospitial Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia

Countries

Malaysia

References

Abdul Kadir NP, Ma ZF, Abdul Hafidz MI, Annamalai C, Jayaraman T, Hamid N, Norhasliza S, Abd Aziz A, Yusof Z, Lee H, Lee YY. Comparing Efficacy and Safety of Empirical vs. Guided Therapy for Non-cardiac Chest Pain: A Pragmatic Randomized Trial. Front Med (Lausanne). 2021 Feb 15;8:605647. doi: 10.3389/fmed.2021.605647. eCollection 2021.

Reference Type: DERIVED

PMID: 33659261 (View on PubMed)

Other Identifiers

14070265

Identifier Type: -

Identifier Source: org_study_id