Chest PainNCT00516854
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
A study testing chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily in people with Chest Pain, run by Hospital Authority, Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- What is being tested?
- chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2002to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Wai Mo Hui, Dr
Kam Chuen Lai, Dr
About this study
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
- Being tested
- chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily
- Keywords
- Non-cardiac chest pain
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlordiazepoxide 5 mg, clidinium 2.5 mg, twice dailyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms scores, quality of life
Measured: 12 Weeks
Secondary outcomes (2)
Compliance
Measured: 12 Weeks
Adverse effects
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startJun 2002
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- The University of Hong Kong
- Investigators
- Ting Kin Cheung, Dr, Principal investigator, Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516854
- Sponsor's protocol ID
- EC1617- 01
- Other IDs
- HARECCTR0500040
- Status last verified
- Jul 2010
- First submitted
- 15 Aug 2007
- Last updated
- 7 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00516854
- Acronym / sponsor ID
- EC1617- 01
- Conditions
- Chest Pain
- Keywords
- Non-cardiac chest pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- The University of Hong Kong
- Study start
- Jun 2002
- Study completion
- Dec 2008 (estimated)
- First posted
- 16 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily | Drug | – |
Primary outcome
Symptoms scores, quality of life
Time frame: 12 Weeks
2 secondary outcomes
Compliance
Time frame: 12 Weeks
Adverse effects
Time frame: 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Kin Cheung, Dr principal investigator
Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chlordiazepoxide 5 mg, clidinium 2.5 mg, twice daily in people with Chest Pain, run by Hospital Authority, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Kin Cheung, Dr ((852) 2855 3989, cheungtk@hkucc.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms scores, quality of life (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010.