Dermatitis, AtopicPhase 3NCT00257569
Study Of Atopic Dermatitis In Pediatrics
A Phase 3 study testing Cetirizine Dry Syrup in people with Dermatitis, Atopic, run by GlaxoSmithKline at 1 site.
Trial summary
To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Cetirizine Dry Syrup
- Type of treatment
- Pill or oral medicine
- How many people
- 278 participants
- Where
- 1 siteLocation not given
- Study dates
- Aug 2005to not given
- 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed as atopic dermatitis
- Giving informed consent
- Children who have 2 grades or more pruritus score.
- Children who require the treatment with external steroid preparation other than face and head.
- Children with a pruritus severity of 2.
- Mild or severe on the fist day of the treatment period.
Who cannot join
- have spastic disease such as epilepsy
- have a history of drug hypersensitivity
- are lactating or possibly pregnant female Children
- have a skin infection, or with zooparasite such as scabies and pediculosis
- cannot avoid the use of external steroid classified into strong, strongest or very strong
- have eczematous otitis externa with perforation in the eardrum
Show all 11Show fewer
- have dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2
- have asthma that requires the treatment with corticosteroid
- have pruritus only on face and head
- have inappropriate complication of dermal disorder that may influence on the evaluation of the study drug
- are undergoing specific desensitization therapy or immunomodulation therapy or phototherapy.
Trial locations and contacts
1 site in 1 country.
Location not given1 site
GSK Investigational Site
About this study
Official title: Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-
To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.
- Conditions
- Dermatitis, Atopic
- Being tested
- Cetirizine Dry Syrup
- Keywords
- Atopic, Pediatric, Dermatitis
- Medical subject headings
- Dermatitis, Atopic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetirizine Dry SyrupDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the severity of pruritus
Secondary outcomes (1)
-changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 278 participants
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
- NCT00257569
- Sponsor's protocol ID
- 104913
- Status last verified
- May 2013
- First submitted
- 21 Nov 2005
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-
- ClinicalTrials.gov ID
- NCT00257569
- Acronym / sponsor ID
- 104913
- Conditions
- Dermatitis, Atopic
- Keywords
- Atopic, Pediatric, Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- First posted
- 23 Nov 2005 (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 verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children diagnosed as atopic dermatitis
- Giving informed consent
- Children who have 2 grades or more pruritus score.
- Children who require the treatment with external steroid preparation other than face and head.
- Children with a pruritus severity of 2.
Key exclusion criteria (11 listed)
- have spastic disease such as epilepsy
- have a history of drug hypersensitivity
- are lactating or possibly pregnant female Children
- have a skin infection, or with zooparasite such as scabies and pediculosis
- cannot avoid the use of external steroid classified into strong, strongest or very strong
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 |
|---|---|---|
| Cetirizine Dry Syrup | Drug | – |
Primary outcome
change in the severity of pruritus
1 secondary outcome
-changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events
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 6 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.
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?
A Phase 3 study testing Cetirizine Dry Syrup in people with Dermatitis, Atopic, run by GlaxoSmithKline at 1 site.
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 6 inclusion and 11 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 6 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. 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 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?
change in the severity of pruritus. 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 6 May 2013.