A Study of the Use of Combination of Anti-cholinergic and Minor Tranquilliser in the Treatment of Non-cardiac Chest Pain - a Double Blind Placebo Controlled Study

July 6, 2010 updated by: Hospital Authority, Hong Kong
Non-cardiac chest pain is a common clinical problem encountered in our practice but at present, the results of treatments are unsatisfactory. The pathogenesis remains unknown but altered motility of the esophagus and psychological factors including anxiety have been implicated as important factors. Reports of the single use of anticholinergic drugs and anxiolytics have yielded conflicting results, has been demonstrated to yield marginal or of no value. However the use of the combination therapy, especially with a double blind fashion have not been reported. On that basis, we propose to use a combination of anti-cholinergic and tranquilliser for the symptomatic treatment of non-cardiac chest pain. The aim of this study is to evaluate the efficacy of combination therapy of anti-cholinergic and anxiolytic drugs in the treatment of non-cardiac chest pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • Queen Mary Hospital
        • Sub-Investigator:
          • Kam Chuen Lai, Dr
        • Sub-Investigator:
          • Wai Mo Hui, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ambulatory patients over the age of 18
  • Patients who are normal endoscopically
  • Patients who do not have symptomatic reflux disease
  • Patient who have normal coronary angiogram or patient with normal exercise radionuclide scan or patient with normal persantin radionuclide scan.

Exclusion Criteria:

  • Patients with history of significant cardiac, renal, pulmonary or hepatic diseases,
  • Patients with history of dyspepsia or peptic ulcer diseases
  • Patient with documented reflux diseases.
  • Patient on drugs that affect gastrointestinal motility in the past 2 weeks
  • Patients who are pregnant or lactating
  • Patients who are suffering from costochrondritis
  • Patients who are known to be sensitive to benzodiazepine or anti-cholinergic
  • Patients with glaucoma and benign prostatic hypertrophy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptoms scores, quality of life
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Compliance
Time Frame: 12 Weeks
12 Weeks
Adverse effects
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Collaborators

The University of Hong Kong

Investigators

  • Principal Investigator: Ting Kin Cheung, Dr, Department of Medicine, Queen Mary Hospital/ The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

August 15, 2007

First Submitted That Met QC Criteria

August 15, 2007

First Posted (Estimate)

August 16, 2007

Study Record Updates

Last Update Posted (Estimate)

July 7, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC1617- 01
  • HARECCTR0500040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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