Recurrent Upper-Respiratory Tract InfectionsPhase 3NCT01948856
CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study
A Phase 3 study testing J022X ST in people with Recurrent Upper-Respiratory Tract Infections, run by Pierre Fabre Medicament at 24 sites in 5 countries.
Trial summary
The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of younger age who develop infectious diseases more frequently than other children of this age in general. Read more about this study
- Who is it for?
- Ages 3 to 4 years
- Conditions the study is for
- Recurrent Upper-Respiratory Tract Infections
- What is being tested?
- J022X ST
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,003 participants
- Where
- 24 sitesin 5 countries
- Study dates
- Sep 2013to 13 Dec 2016
- 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 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with all the following criteria will be eligible for inclusion in Year 1:
- Children, male or female
- Aged 3 to 4 years
- Children known for recurrent URTIs in the past year (based on medical recording or reported history)
- Children at risk for URTI in the physician's opinion (e.g. absence of breastfeeding, hospitalization in the previous year, tonsillectomy or adenoidectomy, parental smoking, daycare institution or nursery school, early schooling, prematurity, low weight at birth, malnutrition, failure to thrive).
- Patients with all the following criteria will be eligible for randomisation in Year 2:
Show all 9Show fewer
- Children, male or female
- Aged 4 to 5 years
- Suffering from RURTI, i.e. at least 6 URTI episodes medically confirmed, with a maximum of 18, during the Year 1 of the study.
Who cannot join
- Presence of diseases (Chronic suppurative otitis media, acute broncho-pulmonary infection, Immune deficiency or disorders, surgery of respiratory tract, cystic fibrosis…) or treatments (chronic use of corticosteroids, bronchodilators, ...) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
Italy7 sites
Study site
Ancona
Study site
L’Aquila
Study site
Milan
Study site
Modena
Study site
Naples
Study site
Roma
Study site
Varese
Poland6 sites
Study site
Lesznowola
Study site
Lublin
Study site
Ostrołęka
Study site
Warsaw
Study site
Węgrów
Study site
Wołomin
Romania6 sites
Study site
Bacau
Study site
Brasov
Study site
Bucharest
Study site
Constanța
Study site
Craiova
Study site
Sibiu
About this study
The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of younger age who develop infectious diseases more frequently than other children of this age in general.
- Being tested
- J022X ST, Placebo
- Keywords
- Recurrent common cold, laryngitis, pharyngitis/tonsillitis, acute rhinitis, acute rhinosinusitis, acute otitis media
- Medical subject headings
- Respiratory Tract Infections, Common Cold, Laryngitis, Pharyngitis, Tonsillitis, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J022X STDrug
Oral administration - During 6 months and according to the approved summary of product characteristics : 1 sachet per day in the morning on an empty stomach
- First month: 4 consecutive days per week during 3 consecutive weeks
- 5 next months: 4 consecutive days per month at monthly intervals
PlaceboDrug
Oral administration - During 6 months : 1 sachet per day in the morning on an empty stomach
- First month: 4 consecutive days per week during 3 consecutive weeks
- 5 next months: 4 consecutive days per month at monthly intervals
| Study group | Role | What they receive |
|---|---|---|
| J022X ST | Experimental | Not described Receives: Drug: J022X ST |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Upper-Respiratory Tract Infections (URTI) episodes medically assessed over year 2
Each URTI episodes will be medically assessed by the investigator by a thorough medical examination.
Measured: at each infectious episode over year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startSep 2013
- Primary completion17 Oct 2016
- Study completion13 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Upper-Respiratory Tract InfectionsStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karim KEDDAD, MD, Study director, Pierre Fabre Medicament
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948856
- Sponsor's protocol ID
- J0022X ST 3 02
- Other IDs
- 2013-001760-31
- Status last verified
- Feb 2017
- First submitted
- 19 Sep 2013
- Last updated
- 3 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study
- ClinicalTrials.gov ID
- NCT01948856
- Acronym / sponsor ID
- J0022X ST 3 02
- Keywords
- Recurrent common cold, laryngitis, pharyngitis/tonsillitis, acute rhinitis, acute rhinosinusitis, acute otitis media
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,003 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- 17 Oct 2016 (actual)
- Study completion
- 13 Dec 2016 (actual)
- First posted
- 24 Sep 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.
The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of younger age who develop infectious diseases more frequently than other children of this age in general.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| J022X ST | Experimental | Drug: J022X ST |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children, male or female
- Aged 3 to 4 years
- Children known for recurrent URTIs in the past year (based on medical recording or reported history)
- Children at risk for URTI in the physician's opinion (e.g. absence of breastfeeding, hospitalization in the previous year, tonsillectomy or adenoidectomy, parental smoking, daycare institution or nursery school, early schooling, prematurity, low weight at birth, malnutrition, failure to thrive).
- Children, male or female
Key exclusion criteria (1 listed)
- Presence of diseases (Chronic suppurative otitis media, acute broncho-pulmonary infection, Immune deficiency or disorders, surgery of respiratory tract, cystic fibrosis…) or treatments (chronic use of corticosteroids, bronchodilators, ...) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study
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 |
|---|---|---|
| J022X STOral administration - During 6 months and according to the approved summary of product characteristics : 1 sachet per day in the morning on an empty stomach * First month: 4 consecutive days per week during 3 consecutive weeks * 5 next months: 4 consecutive days per month at monthly intervals | Drug | J022X ST |
| PlaceboOral administration - During 6 months : 1 sachet per day in the morning on an empty stomach * First month: 4 consecutive days per week during 3 consecutive weeks * 5 next months: 4 consecutive days per month at monthly intervals | Drug | Placebo |
Primary outcome
Number of Upper-Respiratory Tract Infections (URTI) episodes medically assessed over year 2
Time frame: at each infectious episode over year 2
Each URTI episodes will be medically assessed by the investigator by a thorough medical examination.
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 3 Feb 2017.
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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.
Karim KEDDAD, MD study director
Pierre Fabre Medicament
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing J022X ST in people with Recurrent Upper-Respiratory Tract Infections, run by Pierre Fabre Medicament at 24 sites in 5 countries.
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 9 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 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy, Poland, Romania, Lithuania, Russia. 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. Some participants in this study may receive a placebo. 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?
Number of Upper-Respiratory Tract Infections (URTI) episodes medically assessed over year 2 (time frame: at each infectious episode over year 2). 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 3 Feb 2017.