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

NCT00516854 | Unknown

• 2 other identifiers: EC1617- 01HARECCTR0500040
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Non-cardiac chest pain

Outcome Measures

Primary Outcomes (1)

• Symptoms scores, quality of life

  12 Weeks

Secondary Outcomes (2)

• Compliance

  12 Weeks

• Adverse effects

  12 Weeks

Interventions

chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead
• The University of Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Chest Pain

Interventions

Chlordiazepoxide; clidinium

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ting Kin Cheung, Dr

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Kin Cheung, Dr

CONTACT

(852) 2855 3989; cheungtk@hkucc.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 16, 2007
• Study Start: June 1, 2002
• Study Completion: December 1, 2008
• Last Updated: July 7, 2010

Record last verified: 2010-07

Locations

CN (1)