CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01948856
First received: September 19, 2013
Last updated: April 20, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Recurrent Upper-Respiratory Tract Infections
Drug: J022X ST
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • Number of Upper-Respiratory Tract Infections (URTI) episodes medically assessed over year 2 [ Time Frame: at each infectious episode over year 2 ] [ Designated as safety issue: No ]
    Each URTI episodes will be medically assessed by the investigator by a thorough medical examination.


Estimated Enrollment: 1000
Study Start Date: September 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: J022X ST Drug: J022X ST

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
Placebo Comparator: Placebo Drug: Placebo

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

  Eligibility

Ages Eligible for Study:   3 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

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:

  • 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.

Key Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01948856

Locations
Italy
Ancona, Italy
Genova, Italy
L'aquila, Italy
Milano, Italy
Modena, Italy
Napoli, Italy
Padova, Italy
Roma, Italy
Varese, Italy
Lithuania
Kaunas, Lithuania
Panevezys, Lithuania
Vilnius, Lithuania
Poland
Lesznowola, Poland
Lublin, Poland
Ostroleka, Poland
Pruszkow, Poland
Warszawa, Poland
Wegrow, Poland
Wolomin, Poland
Romania
Bacau, Romania
Brasov, Romania
Bucharest, Romania
Constanta, Romania
Craiova, Romania
Sibiu, Romania
Russian Federation
Moscow, Russian Federation
St.Petersburg, Russian Federation
Sponsors and Collaborators
Pierre Fabre Medicament
Investigators
Study Director: Athmane BOUROUBI, MD Pierre Fabre Medicament
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01948856     History of Changes
Other Study ID Numbers: J0022X ST 3 02, 2013-001760-31
Study First Received: September 19, 2013
Last Updated: April 20, 2015
Health Authority: Italy: Ethics Committee
Italy: The Italian Medicines Agency
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ethics Committee
Romania: National Agency for Medicines and Medical Devices
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee

Keywords provided by Pierre Fabre Medicament:
Recurrent common cold
laryngitis
pharyngitis/tonsillitis
acute rhinitis
acute rhinosinusitis
acute otitis media

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 26, 2015