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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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21 May 2018 |
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Main ID: |
ISRCTN28639953 |
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Date of registration:
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06/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical acceptability study in patients suffering from acute hemorrhoidal disease comparing micronized purified flavonoid fraction (MPFF) 1000 mg tablet, to MPFF 500 mg tablet
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Scientific title:
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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) |
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Date of first enrolment:
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16/12/2013 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN28639953 |
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Study type:
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Interventional |
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Study design:
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International multicenter double-blind randomized parallel-group study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Russian Federation
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Serbia
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Yury
Shelygin |
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Address:
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Federal State Institution 'State Scientific Center of Coloproctology' of Ministry of Health of Russian Federation
2, Salyama Adilya Street
117997
Moscow
Russian Federation |
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Telephone:
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- |
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Email:
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clinicaltrials@servier.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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)
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hemorrhoidal disease
Circulatory System
Haemorrhoids
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Intervention(s)
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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
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Primary Outcome(s)
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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
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Secondary ID(s)
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CL3-05682-108
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Source(s) of Monetary Support
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Institut de Recherches Internationales Servier (France)
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Ethics review
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Status:
Approval date:
Contact:
Ethics approval was obtained before recruitment of the first participants
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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13/06/2014 |
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URL:
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