NCT00605605

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2008

Completed
Last Updated

January 31, 2008

Status Verified

January 1, 2008

Enrollment Period

9 months

First QC Date

January 18, 2008

Last Update Submit

January 30, 2008

Conditions

AtherosclerosisSmokingInflammation

Keywords

endothelial functionatherosclerosissmokinginflammationantioxidant

Outcome Measures

Primary Outcomes (1)

  • Endothelial function

    1, 2, 3 and 6 month

Secondary Outcomes (1)

  • 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

Study Arms (1)

1

EXPERIMENTAL
Drug: Dextromethorphan

Interventions

DextromethorphanDRUG

120 mg/day, single once daily dose taken after breakfast by oral route

Also known as: medicon for DM
1

Eligibility Criteria

Age30 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male volunteers who are currently smoking

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

AtherosclerosisSmokingInflammation

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Ping-Yen Liu, MD, PhD

    Assiatant Professor of National Cheng Kung University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2008

First Posted

January 31, 2008

Study Start

March 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

January 31, 2008

Record last verified: 2008-01

Locations

TW(1)