NCT03319121|CompletedPhase 2/3DMC
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Sponsor study identifier
interventional
68
1 country
1
Study Start
March 2015
Actual (reported)Primary Completion
December 2017
Actual (reported)Study Completion
December 2017
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2015
Actual (reported)October 18, 2017
Actual (reported)October 24, 2017
Actual (reported)December 2017
Actual (reported)December 2017
Actual (reported)Non-cardiac chest pain symptoms assessed by visual analog scale (VAS)
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.
8 weeks
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
Participants will be given extended release lansoprazole (Dexlansoprazole, Takeda Pharmaceuticals, Japan) 60 mg daily for 2 weeks
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.
Receive extended release lansoprazole (Dexlansoprazole, Takeda Pharmaceuticals, Japan) 60 mg daily for 2 weeks.
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.
Hospitial Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150, Malaysia
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.
Yeong Yeh Lee, MD, PhD
Universiti Sains Malaysia
68 participants (actual enrollment reported by the registry).
First Submitted
October 18, 2017
First Posted
October 24, 2017
Study Start
March 2015
Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori
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Primary Completion
December 2017
Actual (reported)Study Completion
December 2017
Actual (reported)Last Updated
August 28, 2019
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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