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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chest Pain

Intervention / Treatment
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* Drug: chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms scores, quality of life |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance |  | 12 Weeks | 
| Adverse effects |  | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-cardiac chest pain