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

NCT03319121 ↗

Phase 2/3 Completed 68 enrolled Universiti Sains Malaysia

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2015-03
Primary completion: 2017-12
Completion: 2017-12

Outcome

Met primary endpoint

paper For between-group analysis, mean global pain scores were better with guided vs. empirical group at 8th week (P = 0.005) PMID 33659261 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexlansoprazole	Other / unclassified	30 mg	—
Subject	Dexlansoprazole	Other / unclassified	60 mg	—
Subject	Theophylline	Small molecule	250 mg	—

Indications

No indication recorded.