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

NCT ID: NCT00516854

Last Updated: 2010-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2008-12-31

Brief 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.

Conditions

Chest Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: collaborator

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Ting Kin Cheung, Dr

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Queen Mary Hospital

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Kin Cheung, Dr

Role: CONTACT

cheungtk@hkucc.hku.hk

(852) 2855 3989

Other Identifiers

HARECCTR0500040

Identifier Type: -

Identifier Source: secondary_id

EC1617- 01

Identifier Type: -

Identifier Source: org_study_id