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Vascular Endothelial Protection Effects of Dextromethorphan

This study has been completed.
Sponsor:
Information provided by:
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT00605605
First received: January 18, 2008
Last updated: January 30, 2008
Last verified: January 2008
History of Changes
  Purpose

To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers.


Condition Intervention Phase
Atherosclerosis
Smoking
Inflammation
 Drug: Dextromethorphan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anti-Inflammation & Vascular Endothelial Protection Effects of Dextromethorphan on Heavy Smoker

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • Endothelial function [ Time Frame: 1, 2, 3 and 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surrogate end-points of the study: hs-CRP, sPLA2, matrix metalloproteinase-3, interleukin-6, tumor necrosis factor-alfa receptor II, GSH-Px, and urinary excretion of 8-PGF2alfa [ Time Frame: 1, 2, 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Dextromethorphan
120 mg/day, single once daily dose taken after breakfast by oral route
Other Name: medicon for DM

Detailed Description:

Dextromethorphan (DM), an ingredient widely used in antitussive remedies, had been reported to reduce the inflammation-mediated degeneration of neurons. We recently found that DM can prevent vascular remodeling and neuron injury in animal models of carotid ligation and cerebral ischemia injuries, respectively. It was believed that its action was through the anti-oxidant and NADPH pathway to protect brain cells. However, the mechanism and actual effect on human vascular protection remained unclear.

To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers, this prospective study will be conducted to treat subjects with heavy smoking history with DM or not and evaluate the anti-inflammatory and the improvement of endothelial function.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • healthy male volunteers who are currently smoking

Exclusion Criteria:

  • personal history of hypertension or diabetes mellitus
  • family history with
  • documented premature cardiovascular events
  • cardiovascular-associated sudden death
  • total cholesterol > 240 mg/dL
  • triglyceride > 200 mg/dL
  • low-density lipoprotein > 160 mg/dL.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605605

Locations
Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
Principal Investigator: Ping-Yen Liu, MD, PhD Assiatant Professor of National Cheng Kung University Medical Center
  More Information

No publications provided

Responsible Party: Ping-Yen Liu/ Assitant Professor, National Cheng-Kung University Medical Center
ClinicalTrials.gov Identifier: NCT00605605     History of Changes
Other Study ID Numbers: HR-93-28, 91-B-FA09-2-4 grant number
Study First Received: January 18, 2008
Last Updated: January 30, 2008
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Cheng-Kung University Hospital:
endothelial function
atherosclerosis
smoking
inflammation
antioxidant

Additional relevant MeSH terms:
Atherosclerosis
Inflammation
Smoking
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Habits
Dextromethorphan
 Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Respiratory System Agents

ClinicalTrials.gov processed this record on May 23, 2013