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

Not Applicable

• Conditions: Chest Pain

• Registration Number: NCT00516854
• Lead Sponsor: Hospital Authority, Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2007-08-15
• Study First Submitted QC: 2007-08-15
• Study First Posted: 2007-08-16
• Study Completion: 2008-12
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Symptoms scores, quality of life	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Adverse effects	12 Weeks
Compliance	12 Weeks

Trial Locations

Locations (1)

Queen Mary Hospital; 🇨🇳 Hong Kong, China