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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

Information source: Hospital Authority, Hong Kong
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chest Pain

Intervention: chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Hospital Authority, Hong Kong

Official(s) and/or principal investigator(s):
Ting Kin Cheung, Dr, Principal Investigator, Affiliation: Department of Medicine, Queen Mary Hospital/ The University of Hong Kong

Overall contact:
Ting Kin Cheung, Dr, Phone: (852) 2855 3989, Email: cheungtk@hkucc.hku.hk

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Symptoms scores, quality of life

Secondary outcome:

Compliance

Adverse effects

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Ting Kin Cheung, Dr, Phone: (852) 2855 3989, Email: cheungtk@hkucc.hku.hk

Queen Mary Hospital, Hong Kong, China; Recruiting
Wai Mo Hui, Dr, Sub-Investigator
Kam Chuen Lai, Dr, Sub-Investigator
Benjamin CY Wong, Dr, Sub-Investigator
Additional Information

Starting date: June 2002
Last updated: July 6, 2010

Page last updated: August 23, 2015

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