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

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ClinicalTrials.gov Identifier: NCT01948856
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament

Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Upper-Respiratory Tract Infections Drug: J022X ST Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1003 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2013
Actual Primary Completion Date : October 17, 2016
Actual Study Completion Date : December 13, 2016

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 )
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 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