Back to resultsEffect of GABAB Agonist on Visceral Hyperalgesia in NCCP patientsChinese?
Primary Purpose
Non-Cardiac Chest Pain
Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Baclofen, Diltiazem
Sponsored by
About this trial
This is an interventional treatment trial for Non-Cardiac Chest Pain
Eligibility Criteria
Inclusion Criteria: Consecutive patients with monthly angina-like chest pain and negative coronary angiogram or scintigraphy Age between 18-70 Gastroesophageal reflux disease Psychiatric illness Cerebrovascular accident Active peptic ulceration Heart failure or cardiac bradyarrhythmia Epilepsy Pregnancy or lactating female Previous hypersensitivity to muscle relaxant
Sites / Locations
- Endoscopy Centre, Prince of Wales Hospital
Outcomes
Primary Outcome Measures
Esophageal sensory and pain thresholds
Secondary Outcome Measures
Symptom severity of chest pain at the end of treatment
Evoked potential responses
Full Information
NCT ID
NCT00164801
First Posted
September 9, 2005
Last Updated
March 25, 2008
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00164801
Brief Title
Effect of GABAB Agonist on Visceral Hyperalgesia in NCCP patientsChinese?
Official Title
Is Visceral Hyperalgesia the Culprit of Noncardiac Chest Pain in Chinese? Part 2: Effect of GABAB Agonist on Visceral Hyperalgesia in NCCP Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Why Stopped
Funding ended
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
5. Study Description
Brief Summary
The effect of baclofen (GABAB agonist), diltiazem (muscle relaxant) and placebo will be compared in a double-blinded randomized study for the treatment of NCCP. Cerebral cortical, brainstem and spinal evoked potentials before and after treatment will be evaluated. Results of this study will shed lights on pathogenesis and treatment of NCCP in Chinese.We hypothesize that Baclofen alleviates visceral hyperalgesia in NCCP patients by suppressing afferent sensory pathway.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Cardiac Chest Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Baclofen, Diltiazem
Primary Outcome Measure Information:
Title
Esophageal sensory and pain thresholds
Secondary Outcome Measure Information:
Title
Symptom severity of chest pain at the end of treatment
Title
Evoked potential responses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria:
Consecutive patients with monthly angina-like chest pain and negative coronary angiogram or scintigraphy
Age between 18-70
Gastroesophageal reflux disease
Psychiatric illness
Cerebrovascular accident
Active peptic ulceration
Heart failure or cardiac bradyarrhythmia
Epilepsy
Pregnancy or lactating female
Previous hypersensitivity to muscle relaxant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin CY CU, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Centre, Prince of Wales Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
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Effect of GABAB Agonist on Visceral Hyperalgesia in NCCP patientsChinese?
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