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

Not Applicable

Completed

• Conditions: Hemorrhoidal disease; Circulatory System; Haemorrhoids

• Registration Number: ISRCTN28639953
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27404053

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-06
• Study Completion: 2014-06-13
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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