Effect of GABAB Agonist on Visceral Hyperalgesia in NCCP... | NCT00164801

Studies
Effect of GABAB Agonist on Visceral Hyperalgesia in NCCP patientsChinese?

NCT00164801

Sponsor

Chinese University of Hong Kong

Status

Terminated

Last Update Posted

Mar 26, 2008Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Non-Cardiac Chest Pain

Interventions

Baclofen, Diltiazem

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding ended

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Not provided

Completion Date

Jan 2007Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2008

Last Update Posted Date

Mar 26, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Name	Type	Description	Arm Group Labels	Other Names
Baclofen, Diltiazem	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Esophageal sensory and pain thresholds

Secondary Outcomes

Measure	Description	Time Frame
Symptom severity of chest pain at the end of treatment
Evoked potential responses

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Justin CY CU, MD	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Endoscopy Centre, Prince of Wales Hospital		Hong Kong			China

Intervention Browse Module

MeSH Terms

ID	Term
D001418	Baclofen
D004110	Diltiazem

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided