Condition category
Digestive System
Date applied
24/06/2015
Date assigned
28/08/2015
Last edited
24/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to investigate whether Tasectan Plus is better than treating acute diarrhoea in children with acute gastroenteritis receiving oral rehydration solution (ORS) than when they are treated with ORS alone.

Who can participate?
Children between 3 months to 12 years with acute diarrhoea.

What does the study involve?
Participants are randomly assigned into one of two groups. Those in group 1 are given Tasectan Plus with oral rehydration salts for 5 days. Those in group 2 are given only the oral rehydration salts. The treatment used in the study was according to products’s leaflet. The parents/tutors are asked to present at doctor's office 2 days later (or earlier if necessary as a result of the worsening of symptoms). During this visit the physician reviews the diary regarding the symptoms and any reported side effects. Further follow-up visits occur 5 days after the start of treatment and then again after 10 days.

What are the possible benefits and risks of participating?
Treatment offered in this study has the potential to treat a childs acute diarrhoea. Information obtained from this study may also help the researchers to better treat children aged 3 months - 12 years with acute diarrhoea. The treatments are given to the children according to the approved leaflet of each product. If the child required medical treatment for physical injury or disease directly caused by the use of the medical device in this study they will be reimbursed the necessary expenses for medical treatment.

Where is the study run from?
A total of seven private GPs in Romania.

When is the study starting and how long is it expected to run for?
July 2014 to February 2015

Who is funding the study?
Novintethical Pharma SA (Switzerland)

Who is the main contact?
Mr Manolache Mihal
mihai.manolache@cebis-int.com

Trial website

Contact information

Type

Public

Primary contact

Mr Manolache Mihai

ORCID ID

http://orcid.org/0000-0002-1811-3965

Contact details

CEBIS International
222 Plevnei Street
3rd Floor
Bucharest
060016
Romania
+40731834503
mihai.manolache@cebis-int.com

Additional identifiers

EudraCT number

2014-001814-24

ClinicalTrials.gov number

Protocol/serial number

CNTPK0414

Study information

Scientific title

A multicentre, randomized, open label, two parallel groups (ORS versus ORS + Tasectan Plus) of children aged 3 months to 12 years with acute gastroenteritis (acute infectious diarrhoea).

Acronym

Study hypothesis

Is Tasectan Plus better in reducing the duration of acute infectious diarrhoea in children aged 3 months to 12 years with acute gastroenteritis receiving oral rehydration solution (ORS)?

Ethics approval

Ethical Committee of Scientific Research, Targu Mures, Romania, 08/07/2014

Study design

Multicentre randomized open-label parallel controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Acute gastroenteritis (acute infectious diarrhoea)

Intervention

The intervention used in the study were: Tasectan Plus - a Gelatine Xyloglucan CE mark Medical Device Plus ORS (Oral Rehidration Solution) versus ORS alone. Administration of the treatments was done according to products approved leaflets in each arm. The treatment duration was 5 days.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Occurence of AE

Secondary outcome measures

Reduction of stools

During the study we had 3 visits: Baseline visit, Visit 1 (2 days after baseline), Visit 2 (5 days after baseline). A telephone follow-up visit was performed at 10 days after Visit 2. The method used to measure the outcomes were by using a daily diary which has captured all the necessary information to measure the outcomes.

Overall trial start date

15/07/2014

Overall trial end date

15/02/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 3 months to 12 years with diagnosis of acute gastroenteritis (acute infectious diarrhoea); acute diarrhoea is defined as ‘three or more liquid stools (rated 6 or 7 on Bristol Stool Scale) a day for less than 72 hours’
2. Patient with absent or mild-moderate dehydration which can be addressed through oral rehydration therapy (ORS)
3. Patient for whom oral rehydration therapy (ORS) and diet is considered the appropriate treatment by the treating physician
4. Patients for whom hospitalisation is not needed and can be treated in an out-patient setting
5. Patients for whom antibiotic therapy is considered not necessary by the treating physician
6. Informed consent signed by the legal representative of the child to participate in the clinical trial

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

36

Participant exclusion criteria

1. Infantile colic
2. Diarrhoea consequently to milk/protein intolerance
3. Severe dehydration needing intravenous rehydration
4. Need for hospitalisation
5. Use of antibiotics before the screening visit or need of antibiotics based on the clinical judgement of treating physician
6. Use of antidiarrheal treatment (antimotility, antisecretory, or adsorbent agents) before the screening visit or need of antidiarrheal agents based on the clinical judgement of treating physician
7. Chronic or toxic diarrhoea
8. Impossibility to follow the patient for more than 12 hours

Recruitment start date

15/08/2014

Recruitment end date

15/01/2015

Locations

Countries of recruitment

Romania

Trial participating centre

Private Practice Dr. Pleasea Catalin
805200
Romania

Trial participating centre

Private Practice Dr. Nedelcu Steluta
810289
Romania

Trial participating centre

Private Practice Dr. Opritescu Mirela
920055
Romania

Trial participating centre

Private Practice Dr. Plesea Alina
800537
Romania

Trial participating centre

Private Practice Dr. Ioan Muresan
400529
Romania

Trial participating centre

Private Practice Dr. Celia Tincau
447020
Romania

Trial participating centre

Private Practice Dr. Livia Botic
245600
Romania

Sponsor information

Organisation

Novintethical Pharma SA

Sponsor details

Via Pian Scairolo
11
Pambio-Noranco
Lugano
CH-6915
Switzerland
+41 (0)91 234 15 72
mihai.manolache@cebis-int.com

Sponsor type

Industry

Website

http://www.novintethical.com

Funders

Funder type

Industry

Funder name

Novintethical Pharma SA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

At least one article will be prepared and published in a scientific journal in 2015.

Intention to publish date

01/12/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27212943

Publication citations

Additional files

Editorial Notes

24/05/2016: Publication reference added.