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

This study is currently recruiting participants.

Verified by Hospital Authority, Hong Kong, June 2008

First Received: August 15, 2007 Last Updated: June 23, 2009 History of Changes

Sponsors and Collaborators:	Hospital Authority, Hong Kong The University of Hong Kong
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00516854

Purpose

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.

Condition	Intervention
Chest Pain	Drug: chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Chest Pain

Drug Information available for: Chlordiazepoxide Chlordiazepoxide hydrochloride Clidinium

U.S. FDA Resources

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:

Symptoms scores, quality of life [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:

Compliance [ Time Frame: 12 Weeks ]
Adverse effects [ Time Frame: 12 Weeks ]

Estimated Enrollment:	100
Study Start Date:	June 2002
Estimated Study Completion Date:	December 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516854

Contacts

Contact: Ting Kin Cheung, Dr

(852) 2855 3989

cheungtk@hkucc.hku.hk

Locations

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

Sponsors and Collaborators

Hospital Authority, Hong Kong

The University of Hong Kong

Investigators

Principal Investigator:

Ting Kin Cheung, Dr

Department of Medicine, Queen Mary Hospital/ The University of Hong Kong

More Information

Additional Information:

HAREC Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	EC1617- 01, HARECCTR0500040
Study First Received:	August 15, 2007
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00516854 History of Changes
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

Non-cardiac chest pain

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Cholinergic Antagonists
Psychotropic Drugs
Adjuvants, Immunologic
Central Nervous System Depressants
Anesthetics

Pain
Cholinergic Agents
Chest Pain
Signs and Symptoms
Hypnotics and Sedatives
Anti-Anxiety Agents
Chlordiazepoxide

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Pain
Cholinergic Agents

Pharmacologic Actions
Chest Pain
Adjuvants, Anesthesia
Signs and Symptoms
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Chlordiazepoxide
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009