AtherosclerosisPhase 4NCT00605605
Vascular Endothelial Protection Effects of Dextromethorphan
A Phase 4 study testing Dextromethorphan in people with Atherosclerosis and Smoking, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men only
- Conditions the study is for
- Atherosclerosis, Smoking, Inflammation
- What is being tested?
- Dextromethorphan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2005to Dec 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- healthy male volunteers who are currently smoking
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atherosclerosis, Smoking, Inflammation
- Being tested
- Dextromethorphan
- Keywords
- endothelial function, atherosclerosis, smoking, inflammation, antioxidant
- Medical subject headings
- Atherosclerosis, Smoking, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextromethorphanDrug
Also called medicon for DM
120 mg/day, single once daily dose taken after breakfast by oral route
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Dextromethorphan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Measured: 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
Measured: 1, 2, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startMar 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ping-Yen Liu, MD, PhD, Principal investigator, Assiatant Professor of National Cheng Kung University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605605
- Sponsor's protocol ID
- HR-93-28
- Other IDs
- 91-B-FA09-2-4 grant number
- Status last verified
- Jan 2008
- First submitted
- 18 Jan 2008
- Last updated
- 31 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammation & Vascular Endothelial Protection Effects of Dextromethorphan on Heavy Smoker
- ClinicalTrials.gov ID
- NCT00605605
- Acronym / sponsor ID
- HR-93-28
- Conditions
- Atherosclerosis, Smoking, Inflammation
- Keywords
- endothelial function, atherosclerosis, smoking, inflammation, antioxidant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 31 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Dextromethorphan |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy male volunteers who are currently smoking
Key exclusion criteria (7 listed)
- personal history of hypertension or diabetes mellitus
- family history with
- documented premature cardiovascular events
- cardiovascular-associated sudden death
- total cholesterol > 240 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DextromethorphanAlso: medicon for DM120 mg/day, single once daily dose taken after breakfast by oral route | Drug | 1 |
Primary outcome
Endothelial function
Time frame: 1, 2, 3 and 6 month
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2008.
Related trials for Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping-Yen Liu, MD, PhD principal investigator
Assiatant Professor of National Cheng Kung University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextromethorphan in people with Atherosclerosis and Smoking, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function (time frame: 1, 2, 3 and 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2008.