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...
Date First Received: September 9, 2005
Last Updated: March 25, 2008
Verified by: Chinese University of Hong Kong, March 2008
Clinical Trial Phase: N/A | Start Date: November 2004
Overall Status: Terminated
Estimated Enrollment: 60
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Intervention(s) in this Clinical Trial
- Drug: Baclofen, Diltiazem
Outcome Measures for this Clinical Trial
Primary Measures
- Esophageal sensory and pain thresholds
Secondary Measures
- Symptom severity of chest pain at the end of treatment
- Evoked potential responses
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 70 Years
Clinical Trial Sponsor Information
Lead Sponsor: Chinese University of Hong Kong
Overall Clinical Trial Officials and Contacts
Justin CY CU, MD Principal Investigator Chinese University of Hong Kong
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00164801
Study ID Number: NPB study
ClinicalTrials.gov Identifier: NCT00164801
Health Authority: Hong Kong: Department of Health
Clinical Trials Authorship and Review
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