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Evaluation of the Efficacy and Tolerability of ABO/MEG-B-09 in Children With Acute Cough

NCT ID: NCT01259674

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-04-30

Brief Summary

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The present clinical trial will examine the use of ABO/MEG-B-09 syrup in children with acute cough as compared to a placebo syrup.

Detailed Description

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Subjects will be asked to take 4 doses of 5 ml containing a mixture of honey and other natural ingredients or a placebo syrup everyday, during 8 days. The following outcomes will be noted down in a diary: occurence and severity of diurnal and nocturnal cough events (cough score) and symptoms, impediment of normal life activities (school, sleeping), the number of medical visits and type of medication needed if any.

Conditions

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Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AboMeg-B-09 syrup

Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period

Group Type EXPERIMENTAL

AboMeg-B-09

Intervention Type DEVICE

Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period

Placebo

Placebo syrup

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo syrup: 5ml to be taken 4 times a day during the entire study period

Interventions

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AboMeg-B-09

Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period

Intervention Type DEVICE

Placebo

Placebo syrup: 5ml to be taken 4 times a day during the entire study period

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children aged between 3 and 6
* Acute cough - lasting 1-3 weeks
* Written informed consent by the parents/legal tutors
* Parents/legal tutors must be willing not to give to the child other medications or products for the treatment of cough during the study period, unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study
* Parents/legal tutors must be willing to comply with the study protocol

Exclusion Criteria

* Children treated with immunostimulators and immune regulating drugs during the last month before starting the study
* Children with immunodeficiencies or immune suppression
* Children with chronic diseases - Pulmonary Diseases, Renal insufficiency, Heart diseases
* Children treated with antibiotics, including prophylactic treatment
* Children being treated with systemic corticosteroids - including oral aerosol inhaler
* Children with potential immunosuppressive viral diseases - Measles, Chickenpox, Rubella, Infectious mononucleosis - within the last month
* Children who have participated in previous studies with experimental products within the last month
* Children with asthma or suspected diagnosis of asthma
* Children with bacterial diseases - Pneumonia, Sepsis
* Children with diabetes because of the high content of sugar of the study products - ABO/MEG-B-09 and placebo
* Children allergic to any study product ingredients
* Children/Parents/legal tutors with psychological condition that may, in the investigator's opinion, adversely affect their co-operation with the study protocol - syrup administration or compilation of the diary
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sprim Advanced Life Sciences

OTHER

Sponsor Role collaborator

Aboca Spa Societa' Agricola

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arienne de Jong, PhD

Role: STUDY_CHAIR

Sprim Advanced Life Sciences

Locations

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Santa Maria della Misercordia di Udine Hospital

Udine, Udine, Italy

Site Status

Countries

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Italy

Other Identifiers

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AB-Resp-09

Identifier Type: -

Identifier Source: org_study_id