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Vascular Endothelial Protection Effects of Dextromethorphan

Primary Purpose

Atherosclerosis, Smoking, Inflammation

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Dextromethorphan
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring endothelial function, atherosclerosis, smoking, inflammation, antioxidant

Eligibility Criteria

30 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Endothelial function

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

Full Information

First Posted
January 18, 2008
Last Updated
January 30, 2008
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00605605
Brief Title
Vascular Endothelial Protection Effects of Dextromethorphan
Official Title
Anti-Inflammation & Vascular Endothelial Protection Effects of Dextromethorphan on Heavy Smoker
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Smoking, Inflammation
Keywords
endothelial function, atherosclerosis, smoking, inflammation, antioxidant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Other Intervention Name(s)
medicon for DM
Intervention Description
120 mg/day, single once daily dose taken after breakfast by oral route
Primary Outcome Measure Information:
Title
Endothelial function
Time Frame
1, 2, 3 and 6 month
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-Yen Liu, MD, PhD
Organizational Affiliation
Assiatant Professor of National Cheng Kung University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan

12. IPD Sharing Statement

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Vascular Endothelial Protection Effects of Dextromethorphan

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