Vascular Endothelial Protection Effects of Dextromethorphan

January 30, 2008 updated by: National Cheng-Kung University Hospital

Anti-Inflammation & Vascular Endothelial Protection Effects of Dextromethorphan on Heavy Smoker

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Dextromethorphan
120 mg/day, single once daily dose taken after breakfast by oral route
Other Names:
  • medicon for DM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial function
Time Frame: 1, 2, 3 and 6 month
1, 2, 3 and 6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1, 2, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Investigators

  • Principal Investigator: Ping-Yen Liu, MD, PhD, Assiatant Professor of National Cheng Kung University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

January 18, 2008

First Submitted That Met QC Criteria

January 30, 2008

First Posted (Estimate)

January 31, 2008

Study Record Updates

Last Update Posted (Estimate)

January 31, 2008

Last Update Submitted That Met QC Criteria

January 30, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-93-28
  • 91-B-FA09-2-4 grant number

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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