HEMODEX study- Detralex* versus placebo in the treatment of acute hemorrhoids in patients with acute hemorrhoidal attack. One week, double-blind, randomized, placebo controlled, multicentre study. - HEMODEX

Conditions: Acute hemorrhoidal attack (stage I, II, III) taking no longer than 48 hours
MedDRA version: 5.1Level: PTClassification code 10019022

Registration Number: EUCTR2004-002707-32-CZ

Lead Sponsor: SERVIER s.r.o.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Male and female adults between 18 and 60 years;
presenting an acute hemorhoidal episode of recent onset (48 hours at maximum);
established by anoscopy examination;
stage I, II, III;
presenting an bleeding with a grade of at least 3 - means blood on feces, in toilet bowl and/or anitis with a grade of at least 3 (moderate) on a four point scale rating from 1 to 4 at examination.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient presenting hemorrhoidal manifestations requiring acute surgery;
presenting hemorrhoidal associated with an anal fissure;
presenting permanent prolapsed hemorrhoids (stage IV);
patient having already received venotonics, anticoagulant, anti-platelet, analgetic or antiinflammatory treatment for ongoing episode;
patient receiving topical hemorrhoid treatment for ongoing episode.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparison of anitis, bleeding (reduction of bleeding, time to stop bleeding) and pain due to acute hemorrhoidal attack between 2 groups: treated with placebo versus treated with Detralex.;Secondary Objective: Reduction of the other signs and symptoms of acute hemorhoidal attack.;Primary end point(s): The global efficacy of the treatment will be evaluated on the following main criteria:<br><br>- Bleeding : reduction of bleeding, time to stop of bleeding (evaluation by investigator using a four point rating scale : NO, YES and if YES - 1=soiling, 2=blood on paper by wiping, 3=blood on feces, toilet bowl)<br><br>- anitis : bulging, blush, warming, pain, impaired function (evaluation by investigator after anoscopy using a four point rating scale : 1=absent, 2=mild, 3=moderate, 4=severe)<br><br>- pain (evaluation by the patient using a Visual Analogue Scale)

Secondary Outcome Measures