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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01948856
First received: September 19, 2013
Last updated: February 2, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 ]
    Each URTI episodes will be medically assessed by the investigator by a thorough medical examination.


Enrollment: 1003
Study Start Date: September 2013
Study Completion Date: December 13, 2016
Primary Completion Date: October 17, 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   (Child)
Sexes Eligible for Study:   All
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
L'aquila, Italy
Milano, Italy
Modena, Italy
Napoli, Italy
Roma, Italy
Varese, Italy
Lithuania
Kaunas, Lithuania
Panevezys, Lithuania
Vilnius, Lithuania
Poland
Lesznowola, Poland
Lublin, Poland
Ostroleka, 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: Karim KEDDAD, MD Pierre Fabre Medicament
  More Information

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01948856     History of Changes
Other Study ID Numbers: J0022X ST 3 02
2013-001760-31 ( EudraCT Number )
Study First Received: September 19, 2013
Last Updated: February 2, 2017

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

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

ClinicalTrials.gov processed this record on June 23, 2017