Condition category
Digestive System
Date applied
02/06/2015
Date assigned
11/06/2015
Last edited
13/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Plain English summary under review

Trial website

Contact information

Type

Scientific

Primary contact

Mr Manolache Mihai

ORCID ID

Contact details

222nd Calea Plevnei 3rd Floor
Bucharest
060016
Romania
+40 (0)731834503
mihai.manolache@cebis-int.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NC_TAS_011012

Study information

Scientific title

Safety and efficacy and rapidity of action of Tasectan Plus vs Diosmectite and vs S. Bouliardii in the treatment of acute diarrhea: multicenter, randomized, open label, parallel group, controlled clinical study

Acronym

Study hypothesis

1. Is Tasectan Plus safer than Diosmectite and S. boulardii?
2. Is Tasectan Plus more efficient than Diosmectite and S. boulardii?

Ethics approval

Med trial research, 01/11/2013, ref: 31

Study design

Multicenter open-label parallel-group active treatment controlled randomized clinical study

Primary study design

Interventional

Secondary study design

Randomised parallel 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

Diarrhea

Intervention

Tasectan Plus vs Diosmectite vs S. boulardii

Patients fulfilling the inclusion criteria will be recruited by family doctors during their normal daily practice and randomised for a 2 day treatment. The study duration is expected to be at least 3 days
or maximum 10 days.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Frequency of AE/SAE in each arm

Secondary outcome measures

Efficacy will be evaluated as following:
The patients will assume the first treatment dose at time of recruitment, i.e. already at the doctor's office and will be trained for the self-administration of an ad-hoc symptoms questionnaire to record their stools and symptoms at 1, 3, 6, 12, 24 and 48 hours following the first study dose.
The symptoms recorded will be objective (stools, vomiting and fever) and subjective (nausea,
abdominal pain, and bloating). The stools grading will be according to the Bristol scale, presence of mucus and blood will be also recorded. The intensity of subjective symptoms will be graded by a VAS.

Overall trial start date

25/11/2013

Overall trial end date

01/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Informed consent
2. Subjects of both sex aged over 18
3. Presence of diarrhea defined as occurrence of > 3 stools per day graded 6 or 7 on the Bristol
scale

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Allergy to one of the product ingredients
2. Pregnant women or breastfeeding
3. Recent surgery
4. Serious and/or systemic diseases

Recruitment start date

25/11/2013

Recruitment end date

15/04/2014

Locations

Countries of recruitment

Romania

Trial participating centre

University of Medicine & Pharmacy Targu-Mures
540139
Romania

Trial participating centre

Dr. Pleasea Condratovici Catalin Private Practice
Galati
805200
Romania

Trial participating centre

Dr. Nedelcu Steluta Private Practice
Galati
810289

Trial participating centre

Dr. Rosoga Natalia Private Practice
Targu Jiu
210166
Romania

Trial participating centre

Dr. Gavanescu Mihaela Private Practice
Bucharest
031753

Sponsor information

Organisation

Novintethical Pharma

Sponsor details

Via Pian Scairolo
11
CH-6915 Pambio-Noranco
Lugano
CH-6915
Switzerland
0040213203281
mihai.manolache@cebis-int.com

Sponsor type

Industry

Website

http://www.novintethical.com

Funders

Funder type

Industry

Funder name

Novitethical Pharma SA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26518158

Publication citations

Additional files

Editorial Notes

02/11/2015: Publication reference added.