Acute hemorrhoidal attack (stage I, II, III) taking no longer than 48 hours MedDRA version: 5.1 Level: PT Classification code 10019022
Conditions
Interventions
Trade Name: DETRALEX
Product Name: DETRALEX
Product Code: S05682-F34
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: N.A.
CAS Number: N.A.
Current Sponsor code: S05682-00
Other descriptiv
Sponsors
SERVIER s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - 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) - 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) - pain (evaluation by the patient using a Visual Analogue Scale) | — |
Countries
Czech Republic
Outcome results
None listed