Atopic DermatitisPhase 2/3NCT01244230
Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)
A Phase 2/3 study testing fexofenadine/Allegra (M016455) in people with Atopic Dermatitis, run by Sanofi at 13 sites in Japan.
Trial summary
Primary Objective: To evaluate safety (4 weeks) Secondary Objectives: To evaluate the long-term safety (12 weeks) To evaluate the efficacy To characterize the pharmacokinetic profile Read more about this study
- Who is it for?
- Ages 6 months to 11 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- fexofenadine/Allegra (M016455)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 13 sitesJapan
- Study dates
- Nov 2010to Aug 2011
- Phase
- Phase 2/3
- 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 6 months to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 6 months through 11 years
- Patients with atopic dermatitis
Who cannot join
- Main itching scores are 4 or less than 2 on last three consecutive days before registration.
- Patients who have itching only on face, head, or diaper area.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Japan13 sites
Investigational Site Number 392012
Hitachi-Naka
Investigational Site Number 392001
Isumi
Investigational Site Number 392010
Itoshima-Shi
Investigational Site Number 392002
Katsushika-ku
Investigational Site Number 392006
Kofu
Investigational Site Number 392011
Komae-Shi
Investigational Site Number 392007
Komatsu-Shi
Investigational Site Number 392003
Kōtoku
Investigational Site Number 392013
Nagano
Investigational Site Number 392009
Okayama
Investigational Site Number 392008
Osaka
Investigational Site Number 392004
Setagaya-Ku
Investigational Site Number 392005
Setagaya-Ku
About this study
Official title: An Open-label, Uncontrolled 4-week Study to Assess the Safety, Efficacy and Pharmacokinetics of Allegra® (Dry Syrup Formulation) 15 mg or 30 mg Twice Daily in Pediatric Patients With Atopic Dermatitis
Primary Objective:
To evaluate safety (4 weeks)
Secondary Objectives:
- To evaluate the long-term safety (12 weeks)
- To evaluate the efficacy
- To characterize the pharmacokinetic profile
Read the detailed description
The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase.
- Conditions
- Atopic Dermatitis
- Being tested
- fexofenadine/Allegra (M016455)
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fexofenadine/Allegra (M016455)Drug
Pharmaceutical form:dry syrup formulation to be suspended in water
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Age 6 months - 2 years | Experimental | Patients between 6 months and 2 years old - Type: Experimental Receives: Drug: fexofenadine/Allegra (M016455) |
| Age 2 - 11 years | Experimental | Patients between 2 and 11 years (and under 10.5 kg) Receives: Drug: fexofenadine/Allegra (M016455) |
| Age 2 - 11 years (and over 10.5 kg) | Experimental | Patients between 2 and 11 years (and over 10.5 kg) Receives: Drug: fexofenadine/Allegra (M016455) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: 4 weeks
The number of clinically significant abnormalities for laboratory findings
Measured: 4 weeks
Secondary outcomes (5)
Number of patients with adverse events
Measured: 12 weeks
The number of clinically significant abnormalities for laboratory findings
Measured: 12 weeks
Changes from baseline in main itching scores on patient diary
Measured: 4 weeks
Changes from baseline in pruritus intensity scores assessed by investigator or subinvestigator
Measured: week 2 and 4
Pharmacokinetic parameters of fexofenadine at steady state; AUC
Measured: week 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244230
- Sponsor's protocol ID
- SFY10718
- Other IDs
- U1111-1115-4048
- Status last verified
- Oct 2013
- First submitted
- 15 Nov 2010
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Uncontrolled 4-week Study to Assess the Safety, Efficacy and Pharmacokinetics of Allegra® (Dry Syrup Formulation) 15 mg or 30 mg Twice Daily in Pediatric Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01244230
- Acronym / sponsor ID
- SFY10718
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Nov 2010 (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.
Primary Objective:
To evaluate safety (4 weeks)
Secondary Objectives:
- To evaluate the long-term safety (12 weeks)
- To evaluate the efficacy
- To characterize the pharmacokinetic profile
Detailed description
The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase, up-to 8-week extension phase, and up-to 5-day post-treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Age 6 months - 2 years | Experimental | Drug: fexofenadine/Allegra (M016455)Patients between 6 months and 2 years old - Type: Experimental |
| Age 2 - 11 years | Experimental | Drug: fexofenadine/Allegra (M016455)Patients between 2 and 11 years (and under 10.5 kg) |
| Age 2 - 11 years (and over 10.5 kg) | Experimental | Drug: fexofenadine/Allegra (M016455)Patients between 2 and 11 years (and over 10.5 kg) |
Who may qualify
- Ages
- 6 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged 6 months through 11 years
- Patients with atopic dermatitis
Key exclusion criteria (3 listed)
- Main itching scores are 4 or less than 2 on last three consecutive days before registration.
- Patients who have itching only on face, head, or diaper area.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| fexofenadine/Allegra (M016455)Pharmaceutical form:dry syrup formulation to be suspended in water Route of administration: oral | Drug | Age 2 - 11 years, Age 2 - 11 years (and over 10.5 kg), Age 6 months - 2 years |
Primary outcome
Number of patients with adverse events
Time frame: 4 weeks
The number of clinically significant abnormalities for laboratory findings
Time frame: 4 weeks
5 secondary outcomes
Number of patients with adverse events
Time frame: 12 weeks
The number of clinically significant abnormalities for laboratory findings
Time frame: 12 weeks
Changes from baseline in main itching scores on patient diary
Time frame: 4 weeks
Changes from baseline in pruritus intensity scores assessed by investigator or subinvestigator
Time frame: week 2 and 4
Pharmacokinetic parameters of fexofenadine at steady state; AUC
Time frame: week 4 and 12
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 Oct 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.
Clinical Sciences & Operations study director
Sanofi
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing fexofenadine/Allegra (M016455) in people with Atopic Dermatitis, run by Sanofi at 13 sites 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 2 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 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of patients with adverse events (time frame: 4 weeks). 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 16 Oct 2013.