Back to resultsA 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
Primary Purpose
Chest Pain
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily
Sponsored by
About this trial
This is an interventional treatment trial for Chest Pain focused on measuring Non-cardiac chest pain
Eligibility 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
Sites / Locations
- Queen Mary HospitalRecruiting
Outcomes
Primary Outcome Measures
Symptoms scores, quality of life
Secondary Outcome Measures
Compliance
Adverse effects
Full Information
NCT ID
NCT00516854
First Posted
August 15, 2007
Last Updated
July 6, 2010
Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00516854
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
Non-cardiac chest pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily
Primary Outcome Measure Information:
Title
Symptoms scores, quality of life
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Compliance
Time Frame
12 Weeks
Title
Adverse effects
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Kin Cheung, Dr
Phone
(852) 2855 3989
Email
cheungtk@hkucc.hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Kin Cheung, Dr
Organizational Affiliation
Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wai Mo Hui, Dr
First Name & Middle Initial & Last Name & Degree
Kam Chuen Lai, Dr
First Name & Middle Initial & Last Name & Degree
Benjamin CY Wong, Dr
12. IPD Sharing Statement
Learn more about this trial
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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