NCT00164801

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

March 26, 2008

Status Verified

March 1, 2008

First QC Date

September 9, 2005

Last Update Submit

March 25, 2008

Conditions

Non-Cardiac Chest Pain

Outcome Measures

Primary Outcomes (1)

  • Esophageal sensory and pain thresholds

Secondary Outcomes (2)

  • Symptom severity of chest pain at the end of treatment

  • Evoked potential responses

Interventions

Baclofen, DiltiazemDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Interventions

BaclofenDiltiazem

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Justin CY CU, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

November 1, 2004

Study Completion

January 1, 2007

Last Updated

March 26, 2008

Record last verified: 2008-03

Locations

CN(1)