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Effect of GABAB Agonist on Visceral Hyperalgesia in NCCP patientsChinese?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00164801
Recruitment Status : Terminated (Funding ended)
First Posted : September 14, 2005
Last Update Posted : March 26, 2008
Sponsor:
Information provided by:
Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Non-Cardiac Chest Pain Drug: Baclofen, Diltiazem Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : November 2004
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain




Primary Outcome Measures :
  1. Esophageal sensory and pain thresholds

Secondary Outcome Measures :
  1. Symptom severity of chest pain at the end of treatment
  2. Evoked potential responses


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164801


Locations
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China
Endoscopy Centre, Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Justin CY CU, MD Chinese University of Hong Kong
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ClinicalTrials.gov Identifier: NCT00164801    
Other Study ID Numbers: NPB study
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: March 26, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Hyperalgesia
Chest Pain
Pain
Neurologic Manifestations
Somatosensory Disorders
Sensation Disorders
Nervous System Diseases
Diltiazem
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents