Condition category
Circulatory System
Date applied
05/05/2014
Date assigned
06/06/2014
Last edited
03/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Yury Shelygin

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL3-05682-108

Study information

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)

Acronym

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.

On 03/07/2014 the anticipated end date was changed from 15/07/2014 to 13/06/2014.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

International multicenter double-blind randomized parallel-group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

16/12/2013

Overall trial end date

13/06/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Other

Gender

Both

Target number of participants

150

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

Trial participating centre

Federal State Institution 'State Scientific Center of Coloproctology' of Ministry of Health of Russian Federation
Moscow
117997
Russian Federation

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes