Vasomotor RhinitisPhase 3NCT01509209
Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis
A Phase 3 study testing Pseudoephedrine / Levocetirizine in people with Vasomotor Rhinitis, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Vasomotor Rhinitis
- What is being tested?
- Pseudoephedrine / Levocetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Apr 2013
- Phase
- Phase 3
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of vasomotor rhinitis
Who cannot join
- Significant concomitant medical condition
- Use corticosteroids or other allergy medications during the study
- Considered by investigator as not appropriate to participate in the clinical study with othe reason
Trial locations and contacts
1 site in 1 country.
South Korea1 site
ear, nose and throat, Boramae Hospital
Dongjak, Seoul, 156-707
About this study
Official title: Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial
The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis
Read the detailed description
randomized, double-blind, placebo-controlled, phase 3
- Conditions
- Vasomotor Rhinitis
- Being tested
- Pseudoephedrine / Levocetirizine
- Keywords
- vasomotor, pseudoephedrine, levocetirizine
- Medical subject headings
- Rhinitis, Vasomotor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pseudoephedrine / LevocetirizineDrug
Also called Cossac L
tablet, BID everyday
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo Receives: Drug: Pseudoephedrine / Levocetirizine |
| Cossac L | Experimental | Pseudoephedrine 120mg + Levocetirizine 2.5mg Receives: Drug: Pseudoephedrine / Levocetirizine |
What is being measured
The primary outcome is the main question the study is designed to answer.
TVRSS(Total Vasomotor Rhinitis Symptom Score)
the change from baseline in TVRSS
Measured: 2week
Secondary outcomes (1)
TVRSS, VRSS
- the change from baseline in TVRSS during 1st week and 2nd week
- the change from baseline in each vasomotor rhinitis symptom score at overall, during 1st week/2week
Measured: 1week or 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor RhinitisStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyungmi Park, Ph.D., Study director, Hanmi Pharmaceutical Company Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509209
- Sponsor's protocol ID
- HM-LCT-301
- Status last verified
- May 2013
- First submitted
- 10 Jan 2012
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial
- ClinicalTrials.gov ID
- NCT01509209
- Acronym / sponsor ID
- HM-LCT-301
- Conditions
- Vasomotor Rhinitis
- Keywords
- vasomotor, pseudoephedrine, levocetirizine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Jan 2012 (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.
The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis
Detailed description
randomized, double-blind, placebo-controlled, phase 3
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Pseudoephedrine / Levocetirizineplacebo |
| Cossac L | Experimental | Drug: Pseudoephedrine / LevocetirizinePseudoephedrine 120mg + Levocetirizine 2.5mg |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of vasomotor rhinitis
Key exclusion criteria (3 listed)
- Significant concomitant medical condition
- Use corticosteroids or other allergy medications during the study
- Considered by investigator as not appropriate to participate in the clinical study with othe reason
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 |
|---|---|---|
| Pseudoephedrine / LevocetirizineAlso: Cossac Ltablet, BID everyday | Drug | Cossac L, Placebo |
Primary outcome
TVRSS(Total Vasomotor Rhinitis Symptom Score)
Time frame: 2week
the change from baseline in TVRSS
1 secondary outcome
TVRSS, VRSS
Time frame: 1week or 2 week
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 23 May 2013.
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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.
Kyungmi Park, Ph.D. study director
Hanmi Pharmaceutical Company Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pseudoephedrine / Levocetirizine in people with Vasomotor Rhinitis, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
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 3 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 23 May 2013. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
TVRSS(Total Vasomotor Rhinitis Symptom Score) (time frame: 2week). 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 23 May 2013.