NCT01948856

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,003

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2013

Typical duration for phase_3

Geographic Reach
5 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2016

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

3.1 years

First QC Date

September 19, 2013

Last Update Submit

February 2, 2017

Conditions

Recurrent Upper-Respiratory Tract Infections

Keywords

Recurrent common coldlaryngitispharyngitis/tonsillitisacute rhinitisacute rhinosinusitisacute otitis media

Outcome Measures

Primary Outcomes (1)

  • 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.

    at each infectious episode over year 2

Study Arms (2)

J022X ST

EXPERIMENTAL
Drug: J022X ST

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

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

J022X ST
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

Placebo

Eligibility Criteria

Age3 Years - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Ancona, Italy

Location

Unknown Facility

L’Aquila, Italy

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Modena, Italy

Location

Unknown Facility

Napoli, Italy

Location

Unknown Facility

Roma, Italy

Location

Unknown Facility

Varese, Italy

Location

Unknown Facility

Kaunas, Lithuania

Location

Unknown Facility

Panevezys, Lithuania

Location

Unknown Facility

Vilnius, Lithuania

Location

Unknown Facility

Lesznowola, Poland

Location

Unknown Facility

Lublin, Poland

Location

Unknown Facility

Ostrołęka, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Węgrów, Poland

Location

Unknown Facility

Wołomin, Poland

Location

Unknown Facility

Bacau, Romania

Location

Unknown Facility

Brasov, Romania

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Constanța, Romania

Location

Unknown Facility

Craiova, Romania

Location

Unknown Facility

Sibiu, Romania

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsCommon ColdLaryngitisPharyngitisTonsillitisOtitis Media

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesLaryngeal DiseasesOtorhinolaryngologic DiseasesPharyngeal DiseasesStomatognathic DiseasesOtitisEar Diseases

Study Officials

  • Karim KEDDAD, MD

    Pierre Fabre Medicament

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2013

First Posted

September 24, 2013

Study Start

September 1, 2013

Primary Completion

October 17, 2016

Study Completion

December 13, 2016

Last Updated

February 3, 2017

Record last verified: 2017-02

Locations

IT(7)RO(6)RU(2)LI(3)PL(6)