Effect of GABAB Agonist on Visceral Hyperalgesia in NCCP patientsChinese?

This study has been terminated.

( Funding ended )

First Received: September 9, 2005 Last Updated: March 25, 2008 History of Changes

Sponsor:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00164801

Purpose

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.

Condition	Intervention
Non-Cardiac Chest Pain	Drug: Baclofen, Diltiazem

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Chest Pain

Drug Information available for: Verapamil Diltiazem hydrochloride Dexverapamil Diltiazem Diltiazem malate Verapamil hydrochloride Baclofen

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

Esophageal sensory and pain thresholds

Secondary Outcome Measures:

Symptom severity of chest pain at the end of treatment
Evoked potential responses

Enrollment:	60
Study Start Date:	November 2004
Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164801

Locations

China
Endoscopy Centre, Prince of Wales Hospital
Hong Kong, China

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:

Justin CY CU, MD

Chinese University of Hong Kong

More Information

No publications provided

Study ID Numbers:	NPB study
Study First Received:	September 9, 2005
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00164801 History of Changes
Health Authority:	Hong Kong: Department of Health

Additional relevant MeSH terms:

Sensation Disorders
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Calcium Channel Blockers
Pain
Cardiovascular Agents
Antihypertensive Agents
Hyperalgesia

Pharmacologic Actions
Chest Pain
Membrane Transport Modulators
Signs and Symptoms
Somatosensory Disorders
Therapeutic Uses
Diltiazem
Neurologic Manifestations

ClinicalTrials.gov processed this record on February 08, 2010