Effect of GABAB Agonist on Visceral Hyperalgesia in NCCP patientsChinese?

Non-Cardiac Chest Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00164801
• Other study ID #: NPB study
• Status: Terminated
• Phase: N/A
• First received: September 9, 2005
• Last updated: March 25, 2008
• Start date: November 2004
• Est. completion date: January 2007

Study information

• Verified date: March 2008
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: January 2007
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chest Pain
• Hyperalgesia
• Non-Cardiac Chest Pain

Intervention

Drug:
• Baclofen, Diltiazem

Locations

Country	Name	City	State
China	Endoscopy Centre, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophageal sensory and pain thresholds
Secondary	Symptom severity of chest pain at the end of treatment
Secondary	Evoked potential responses