Rhinitis, Allergic, SeasonalNCT00762983
Observation of Use of Claritin (Loratadine) Tablet, RediTabs, and Dry Syrup in Children (Study P05834)(COMPLETED)
An observational study of Rhinitis, Allergic, Seasonal and Rhinitis, Allergic, Perennial, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to collect information on unexpected adverse reactions (ADRs), how often ADRs occur, and factors that can affect the safety and effectiveness of Claritin (loratadine) when used in children. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria
- What is being tested?
- loratadine
- Type of treatment
- Pill or oral medicine
- How many people
- 1,003 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Feb 2009
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients who are treated with Claritin at a department of pediatrics, department of otorhinology, department of dermatology, etc. at approximately 120 institutions
Who may be able to join
- Pediatric patients aged 3 to 15 years who are treated with Claritin for any of the following reasons: allergic rhinitis, urticaria, itching due to skin disease (eczema, dermatitis, or pruritus cutaneous)
Who cannot join
- (None)
About this study
Official title: Claritin® Tablet 10 mg, Claritin® RediTabs® 10 mg, Claritin® Dry Syrup 1% Drug Use Investigation (Pediatrics)
The purpose of this study is to collect information on unexpected adverse reactions (ADRs), how often ADRs occur, and factors that can affect the safety and effectiveness of Claritin (loratadine) when used in children. Patients will be observed while they are taking Claritin, and ADRs and symptom scores will be recorded. At the end of treatment, improvement in symptoms will be recorded.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
- Being tested
- loratadine
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loratadineDrug
Also called Claritin, SCH 29851
Claritin Tablet 10 mg, Claritin RediTabs 10 mg: For pediatric patients aged 7 years and older, 10 mg of loratadine is orally administered once daily after a meal in usual cases.
Claritin Dry Syrup 1%: For pediatric patients aged 3 to < 7 years, 5 mg loratadine (0.5 g dry syrup); and for pediatric patients aged 7 years and older, 10 mg of loratadine (1 g dry syrup) is dissolved immediately before use and orally administered once daily after a meal in usual cases.
The observation period will not be specified.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Pediatric patients who are treated with Claritin for any of the following reasons: allergic rhinitis, urticaria, itching due to skin disease (eczema, dermatitis, or pruritus cutaneous) Receives: Drug: loratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unexpected adverse drug reactions (ADRs) that had not been detected in pre-approval clinical studies
Measured: During and at the end of the observation period
Allergic rhinitis: nasal symptom scores (paroxysmal sneeze, nasal discharge, nasal congestion, and intranasal itching)
Measured: Before the start of treatment, during the observation period, and at the end of the observation period
Urticaria, eczema, dermatitis, pruritus cutaneous: severity score of itching
Measured: Before the start of treatment, during the observation period, and at the end of the observation period
Secondary outcomes (2)
Allergic rhinitis: Markedly improved, Moderately improved, Mildly improved, Unchanged, Worsened, Unassessable
Measured: At the end of the observation period
Urticaria, eczema, dermatitis, pruritus cutaneous: Resolved, Improved, Unchanged, Worsened, Unassessable
Measured: At the end of the observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762983
- Sponsor's protocol ID
- P05834
- Status last verified
- Feb 2015
- First submitted
- 29 Sep 2008
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Claritin® Tablet 10 mg, Claritin® RediTabs® 10 mg, Claritin® Dry Syrup 1% Drug Use Investigation (Pediatrics)
- ClinicalTrials.gov ID
- NCT00762983
- Acronym / sponsor ID
- P05834
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,003 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 30 Sep 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.
The purpose of this study is to collect information on unexpected adverse reactions (ADRs), how often ADRs occur, and factors that can affect the safety and effectiveness of Claritin (loratadine) when used in children. Patients will be observed while they are taking Claritin, and ADRs and symptom scores will be recorded. At the end of treatment, improvement in symptoms will be recorded.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: loratadinePediatric patients who are treated with Claritin for any of the following reasons: allergic rhinitis, urticaria, itching due to skin disease (eczema, dermatitis, or pruritus cutaneous) |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients who are treated with Claritin at a department of pediatrics, department of otorhinology, department of dermatology, etc. at approximately 120 institutions
Key inclusion criteria (1 listed)
- Pediatric patients aged 3 to 15 years who are treated with Claritin for any of the following reasons: allergic rhinitis, urticaria, itching due to skin disease (eczema, dermatitis, or pruritus cutaneous)
Key exclusion criteria (1 listed)
- (None)
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 |
|---|---|---|
| loratadineAlso: Claritin, SCH 29851Claritin Tablet 10 mg, Claritin RediTabs 10 mg: For pediatric patients aged 7 years and older, 10 mg of loratadine is orally administered once daily after a meal in usual cases. Claritin Dry Syrup 1%: For pediatric patients aged 3 to < 7 years, 5 mg loratadine (0.5 g dry syrup); and for pediatric patients aged 7 years and older, 10 mg of loratadine (1 g dry syrup) is dissolved immediately before use and orally administered once daily after a meal in usual cases. The observation period will not be specified. | Drug | Group 1 |
Primary outcome
Unexpected adverse drug reactions (ADRs) that had not been detected in pre-approval clinical studies
Time frame: During and at the end of the observation period
Allergic rhinitis: nasal symptom scores (paroxysmal sneeze, nasal discharge, nasal congestion, and intranasal itching)
Time frame: Before the start of treatment, during the observation period, and at the end of the observation period
Urticaria, eczema, dermatitis, pruritus cutaneous: severity score of itching
Time frame: Before the start of treatment, during the observation period, and at the end of the observation period
2 secondary outcomes
Allergic rhinitis: Markedly improved, Moderately improved, Mildly improved, Unchanged, Worsened, Unassessable
Time frame: At the end of the observation period
Urticaria, eczema, dermatitis, pruritus cutaneous: Resolved, Improved, Unchanged, Worsened, Unassessable
Time frame: At the end of the observation period
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 13 Feb 2015.
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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 Rhinitis, Allergic, Seasonal and Rhinitis, Allergic, Perennial, run by Merck Sharp & Dohme LLC.
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 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 13 Feb 2015. 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?
Unexpected adverse drug reactions (ADRs) that had not been detected in pre-approval clinical studies (time frame: During and at the end of the observation period). The study lists 3 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 13 Feb 2015.