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

Chest Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00516854
• Other study ID #: EC1617- 01
• Secondary ID: HARECCTR0500040
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2007
• Last updated: July 6, 2010
• Start date: June 2002
• Est. completion date: December 2008

Study information

• Verified date: July 2010
• Source: Hospital Authority, Hong Kong
• Contact: Ting Kin Cheung, Dr
• Phone: (852) 2855 3989
• Email: cheungtk[@]hkucc.hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2008
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Chest Pain

Intervention

Drug:
• chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong	The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms scores, quality of life		12 Weeks
Secondary	Compliance		12 Weeks
Secondary	Adverse effects		12 Weeks

External Links

•   HAREC Clinical Trial Registry