Clinical acceptability study in patients suffering from acute hemorrhoidal disease comparing micronized purified flavonoid fraction (MPFF) 1000 mg tablet, to MPFF 500 mg tablet

ISRCTN	ISRCTN28639953
DOI	https://doi.org/10.1186/ISRCTN28639953
Secondary identifying numbers	CL3-05682-108

Submission date: 05/05/2014
Registration date: 06/06/2014
Last edited: 18/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Contact information

Prof Yury Shelygin
Scientific

Federal State Institution 'State Scientific Center of Coloproctology' of Ministry of Health of Russian Federation
2, Salyama Adilya Street
Moscow
117997
Russian Federation

Email	clinicaltrials@servier.com

Study information

Study design	International multicenter double-blind randomized parallel-group study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Clinical acceptability study of micronized purified flavonoid fraction 1000 mg tablets and micronized purified flavonoid fraction 500 mg tablets after 7 days of treatment followed by a follow-up period of 7 days in patients suffering from acute hemorroidal disease (HD)
Study hypothesis	To demonstrate the clinical acceptability of MPFF 1000 mg and MPFF 500 mg tablets in patients suffering from hemorrhoidal disease during a 7-day treatment period, followed by follow-up period of 7 days.
Ethics approval(s)	Ethics approval was obtained before recruitment of the first participants
Condition	Hemorrhoidal disease
Intervention	All participants will receive 3 g/day of MPFF during 4 days and 2 g/day of MPFF during the 3 following days. Participants will be randomly allocated to receive this dose in the form of either 500 mg tablets or 1000 mg tablets. After the 7 days of treatment there will be a follow-up period of 7 days
Intervention type	Other
Primary outcome measure	Safety (clinical acceptability) assessed at each visit (day 0, day 7, day 14). Safety assessment takes into account adverse events, weight, sitting blood pressure and heart rate, bleeding cessation evaluation by a 4-point scale, pain evaluation by Visual Analog Scale and laboratory examination
Secondary outcome measures	N/A
Overall study start date	16/12/2013
Overall study end date	13/06/2014

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	150
Participant inclusion criteria	1. Male or female patient aged 18 to 75 years old (inclusive) 2. Out-patient 3. Suffering from acute and non-complicated hemorrhoidal episode (acute pain with oedema assessed by a Visual Analog Scale and/or bleeding assessed by a 4-point scale)
Participant exclusion criteria	1. Pregnancy, breastfeeding or possibility of becoming pregnant 2. Complicated hemorrhoidal disease (requiring surgery, stage IV prolapsed hemorrhoids, anal fissure, associated infection), patients presenting other anal bleeding pathologies 3. Laser therapy, anal surgery, canal radiation before inclusion
Recruitment start date	16/12/2013
Recruitment end date	13/06/2014

Locations

Countries of recruitment

Russian Federation
Serbia

Study participating centre

Federal State Institution 'State Scientific Center of Coloproctology' of Ministry of Health of Russian Federation

Moscow
117997
Russian Federation

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Current version as of 28/03/2018: Summary results are published in https://clinicaltrials.servier.com. For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature. IPD sharing plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014. Previous version as of 24/01/2018: Publication plan: All phases - Interventional studies ending before 01/10/2018: Summary results will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study. All phases - Interventional studies ending after 01/10/2018: Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study. Phase 3 only - The results will be published in scientific literature within 18 months after the end of the study.
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ if a Marketing Authorisation has been granted after 2014.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Results article	results	01/11/2016		Yes	No

Editorial Notes

18/04/2018: Internal review
28/03/2018: The publication and dissemination plan has been changed.
19/12/2017: publication reference added.
04/12/2017: results summary added.
09/05/2017: contact email address added.
03/07/2014: the anticipated end date was changed from 15/07/2014 to 13/06/2014.