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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 because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00516854
First received: August 15, 2007
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516854

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

Locations
China
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
Investigators
Principal Investigator: Ting Kin Cheung, Dr Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00516854     History of Changes
Other Study ID Numbers: EC1617- 01, HARECCTR0500040
Study First Received: August 15, 2007
Last Updated: July 6, 2010
Health Authority: Hong Kong: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 21, 2013