UrticariaNCT02238249
Study to Investigate the Safety and Efficacy of Alesion® in Japanese Paediatric Patients With Urticaria
An observational study of Urticaria, run by Boehringer Ingelheim.
Trial summary
Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in daily clinical practice in Japanese paediatric patients with urticaria Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urticaria
- What is being tested?
- Alesion®
- Type of treatment
- Pill or oral medicine
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Sep 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with urticaria and without experience in treatment with epinastine are selected by physicians at medical institutions
Who may be able to join
- All the patients who:
- haven't treatment experience of epinastine product entered the survey;
- have urticaria
Who cannot join
- Alesion® Dry Syrup is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Dry Syrup in package insert. However, it was unknown whether a patient is hypersensitive to the ingredients of the product in almost cases. And this survey was drug utilization study to observe actual use in any patients. Therefore exclusion criteria are not set in the protocol
About this study
Official title: Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Dry Syrup -Special Drug Use-Results Survey of Alesion® Dry Syrup-
Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in daily clinical practice in Japanese paediatric patients with urticaria
- Conditions
- Urticaria
- Being tested
- Alesion®
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alesion®Drug
Dry Syrup
| Study group | Role | What they receive |
|---|---|---|
| paediatric patients with urticaria | Not described Receives: Drug: Alesion® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions
classified by Medical Dictionary for Regulatory Activities (MedDRA)
Measured: up to 2 years
Incidence of adverse drug reactions classified by patient's background/treatment factors
Measured: up to 2 years
Secondary outcomes (1)
Overall assessment of efficacy by investigator on a 3-point scale
Measured: after 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startOct 2005
- Primary completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrticariaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238249
- Sponsor's protocol ID
- 262.294
- Status last verified
- Sep 2014
- First submitted
- 11 Sep 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Dry Syrup -Special Drug Use-Results Survey of Alesion® Dry Syrup-
- ClinicalTrials.gov ID
- NCT02238249
- Acronym / sponsor ID
- 262.294
- Conditions
- Urticaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Sep 2007 (actual)
- First posted
- 12 Sep 2014 (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.
Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in daily clinical practice in Japanese paediatric patients with urticaria
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paediatric patients with urticaria | – | Drug: Alesion® |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with urticaria and without experience in treatment with epinastine are selected by physicians at medical institutions
Key inclusion criteria (3 listed)
- All the patients who:
Key exclusion criteria (1 listed)
- Alesion® Dry Syrup is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Dry Syrup in package insert. However, it was unknown whether a patient is hypersensitive to the ingredients of the product in almost cases. And this survey was drug utilization study to observe actual use in any patients. Therefore exclusion criteria are not set in the protocol
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 |
|---|---|---|
| Alesion®Dry Syrup | Drug | paediatric patients with urticaria |
Primary outcome
Incidence of adverse drug reactions
Time frame: up to 2 years
classified by Medical Dictionary for Regulatory Activities (MedDRA)
Incidence of adverse drug reactions classified by patient's background/treatment factors
Time frame: up to 2 years
1 secondary outcome
Overall assessment of efficacy by investigator on a 3-point scale
Time frame: after 1 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 12 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Urticaria, run by Boehringer Ingelheim.
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 3 inclusion and 1 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 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of adverse drug reactions (time frame: up to 2 years). The study lists 2 primary outcomes in all. 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 12 Sep 2014.