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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Symptoms scores, quality of life
    • Time Frame: 12 Weeks

Secondary Measures

  • Compliance
    • Time Frame: 12 Weeks
  • Adverse effects
    • Time Frame: 12 Weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Hospital Authority, Hong Kong
  • Collaborator
    • The University of Hong Kong
  • Overall Official(s)
    • Ting Kin Cheung, Dr, Principal Investigator, Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
  • Overall Contact(s)
    • Ting Kin Cheung, Dr, (852) 2855 3989, cheungtk@hkucc.hku.hk

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.