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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Recruiting
The University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong Identifier:
First received: August 15, 2007
Last updated: July 6, 2010
Last verified: July 2010
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 Intervention
Chest Pain Drug: chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hospital Authority, Hong Kong:

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

Secondary Outcome Measures:
  • Compliance [ Time Frame: 12 Weeks ]
  • Adverse effects [ Time Frame: 12 Weeks ]

Estimated Enrollment: 100
Study Start Date: June 2002
Estimated Study Completion Date: December 2008

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00516854

Contact: Ting Kin Cheung, Dr (852) 2855 3989

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
  More Information

Additional Information: Identifier: NCT00516854     History of Changes
Other Study ID Numbers: EC1617- 01
Study First Received: August 15, 2007
Last Updated: July 6, 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
Cholinergic Antagonists
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
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 processed this record on September 19, 2017