Allergic RhinitisNCT02020902
Post Marketing Surveillance for Contac Bien Z in Japan
An observational study of Allergic Rhinitis and Seasonal Allergic Rhinitis, run by GlaxoSmithKline at 1 site in Japan.
Trial summary
This is a post-marketing surveillance study on a marketed cetrizine hydrochloride formulation. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Allergic Rhinitis, Seasonal Allergic Rhinitis
- What is being tested?
- Cetrizine hydrochloride
- How many people
- 1,552 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2013to Jan 2016
- Phase
- Observational
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who purchase the marketed cetrizine hydrochloride formulation from pharmacy stores in Japan.
Who may be able to join
- Male and female participants, between 15-65 years of age, who purchase the marketed cetrizine hydrochloride formulation
Who cannot join
- Who have ever experienced allergic symptoms by taking this medication or any component of this medication, piperazine derivative (including levocetirizine, hydroxizine)
- Those who have been under 15en diagnosed with kidney disease
- Children under 15 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contac Bien Z Adverse Effect Survey
This is a post-marketing surveillance study on a marketed cetrizine hydrochloride formulation.
- Conditions
- Allergic Rhinitis, Seasonal Allergic Rhinitis
- Being tested
- Cetrizine hydrochloride
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetrizine hydrochlorideOther
As provided on the patient information leaflet
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events after having cetrizine hydrochloride
Participants will answer a questionnaire which consists of questions on safety of the marketed cetrizine hydrochloride formulation.
Measured: At baseline
Secondary outcomes (1)
Efficacy of the marketed cetrizine hydrochloride formulation
Participants will answer a questionnaire which consists of questions on their satisfaction after taking the marketed cetrizine hydrochloride formulation. The efficacy will be measured on a 4 point scale (1 Efficacious; 2 Somewhat efficacious; 3 Not efficacious; 4 Not known)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,552 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020902
- Sponsor's protocol ID
- 200638
- Other IDs
- RH01905
- Status last verified
- May 2016
- First submitted
- 19 Dec 2013
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contac Bien Z Adverse Effect Survey
- ClinicalTrials.gov ID
- NCT02020902
- Acronym / sponsor ID
- 200638
- Conditions
- Allergic Rhinitis, Seasonal Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,552 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Dec 2013 (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.
This is a post-marketing surveillance study on a marketed cetrizine hydrochloride formulation.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who purchase the marketed cetrizine hydrochloride formulation from pharmacy stores in Japan.
Key inclusion criteria (1 listed)
- Male and female participants, between 15-65 years of age, who purchase the marketed cetrizine hydrochloride formulation
Key exclusion criteria (3 listed)
- Who have ever experienced allergic symptoms by taking this medication or any component of this medication, piperazine derivative (including levocetirizine, hydroxizine)
- Those who have been under 15en diagnosed with kidney disease
- Children under 15 years of age
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 |
|---|---|---|
| Cetrizine hydrochlorideAs provided on the patient information leaflet | Other | – |
Primary outcome
Adverse events after having cetrizine hydrochloride
Time frame: At baseline
Participants will answer a questionnaire which consists of questions on safety of the marketed cetrizine hydrochloride formulation.
1 secondary outcome
Efficacy of the marketed cetrizine hydrochloride formulation
Time frame: At baseline
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 16 May 2016.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis and Seasonal Allergic Rhinitis, run by GlaxoSmithKline at 1 site in Japan.
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 16 May 2016. 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 Japan. 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.
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?
Adverse events after having cetrizine hydrochloride (time frame: At baseline). 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 16 May 2016.