Vascular Endothelial Protection Effects of Dextromethorphan

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605605
• Other study ID #: HR-93-28
• Secondary ID: 91-B-FA09-2-4 gr
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2008
• Last updated: January 30, 2008
• Start date: March 2005
• Est. completion date: December 2005

Study information

• Verified date: January 2008
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Inflammation
• Smoking

Intervention

Drug:
• Dextromethorphan
120 mg/day, single once daily dose taken after breakfast by oral route

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function		1, 2, 3 and 6 month	No
Secondary	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		1, 2, 3 and 6 months	No