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

NCT03319121 | Completed Phase 2 DMC

• 1 other identifier: 14070265
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Non Cardiac Chest Pain

Keywords

Non cardiac chest pain; Empirical therapy; Guided therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

Empirical therapy group

EXPERIMENTAL

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

Drug: Empirical therapy group

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.

Drug: Guided therapy group

Interventions

Empirical therapy group DRUG

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

Also known as: Dexlansoprazole

Empirical therapy group

Guided therapy group 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.

Also known as: Dexlansoprazole and/or Theophylline SR

Guided therapy group

Eligibility Criteria

• Age: 18 Months - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Hospitial Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 33659261 DERIVED

MeSH Terms

Interventions

Dexlansoprazole

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yeong Yeh Lee, MD, PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr

Model Details: Participants will be randomly allocated into either the empirical group or guided group for 8 weeks.

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 24, 2017
• Study Start: March 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

MY (1)