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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03319121 |
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Date of registration:
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18/10/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Evaluation of Effectiveness Between Empirical and Guided Therapy for Unexplained Non-Cardiac Chest Pain
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Scientific title:
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The Evaluation of Effectiveness Between Empirical and Guided Therapy for Unexplained Non-Cardiac Chest Pain |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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68 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03319121 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Yeong Yeh Lee, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universiti Sains Malaysia |
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Key inclusion & exclusion criteria
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Inclusion Criteria: Participants with chest pain but normal angiogram or a negative stress
test or normal electrocardiogram and cardiac enzyme.
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.
Age minimum:
18 Months
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non Cardiac Chest Pain
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Intervention(s)
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Drug: Guided therapy group
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Drug: Empirical therapy group
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Primary Outcome(s)
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Non-cardiac chest pain symptoms assessed by visual analog scale (VAS)
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Non-cardiac chest pain symptoms assessed by quality of life in reflux and dyspepsia questionnaire (QOLRAD)
[Time Frame: 8 weeks]
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Non-cardiac chest pain symptoms assessed by gastroesophageal reflux disease questionnaire (GERDQ)
[Time Frame: 8 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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