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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

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ClinicalTrials.gov Identifier: NCT00516854
Recruitment Status : Unknown
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Recruiting
First Posted : August 16, 2007
Last Update Posted : July 7, 2010
The University of Hong Kong
Information provided by:
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.

Condition or disease Intervention/treatment
Chest Pain Drug: chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : June 2002
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain
U.S. FDA Resources

Primary Outcome Measures :
  1. Symptoms scores, quality of life [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Compliance [ Time Frame: 12 Weeks ]
  2. Adverse effects [ Time Frame: 12 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516854

Contact: Ting Kin Cheung, Dr (852) 2855 3989 cheungtk@hkucc.hku.hk

Queen Mary Hospital Recruiting
Hong Kong, China
Sub-Investigator: Wai Mo Hui, Dr         
Sub-Investigator: Kam Chuen Lai, Dr         
Sub-Investigator: Benjamin CY Wong, Dr         
Sponsors and Collaborators
Hospital Authority, Hong Kong
The University of Hong Kong
Principal Investigator: Ting Kin Cheung, Dr Department of Medicine, Queen Mary Hospital/ The University of Hong Kong

Additional Information:
ClinicalTrials.gov Identifier: NCT00516854     History of Changes
Other Study ID Numbers: EC1617- 01
First Posted: August 16, 2007    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

Keywords provided by Hospital Authority, Hong Kong:
Non-cardiac chest pain

Additional relevant MeSH terms:
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cholinergic Agents
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Cholinergic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adjuvants, Anesthesia
Central Nervous System Depressants
Psychotropic Drugs
GABA Modulators
GABA Agents
Autonomic Agents
Peripheral Nervous System Agents