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

February 2, 2017 updated by: Pierre Fabre Medicament
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1003

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 4 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at each infectious episode over year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

October 17, 2016

Study Completion (ACTUAL)

December 13, 2016

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (ESTIMATE)

September 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J0022X ST 3 02
  • 2013-001760-31 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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