Effect of GABAB Agonist on Visceral Hyperalgesia in NCCP patientsChinese?

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00164801
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 26
• Patients Per Site Per Month: 2.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Cardiac Chest Pain	Drug: Baclofen, Diltiazem	N/A

Study Design

• Study Type: Interventional
• 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: Nov 1, 2004
• Actual Study Completion Date: Jan 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00164801
• Other Study ID Numbers: NPB study
• First Posted: Sep 14, 2005
• Last Update Posted: Mar 26, 2008
• Last Verified: Mar 1, 2008

• Additional relevant MeSH terms: Hyperalgesia; Chest Pain; Diltiazem; Baclofen

Study Results

No Results Posted as of Mar 26, 2008