Preliminary evaluation of efficacy and tolerability of the association mesalazine 1g nifedipine 10mg in the treatment of tenesmus in patients suffering of distal ulcerative cholitis. Open study, phase II, two steps according to Simon - ND

Conditions: Tenesmus in patients with distal ulcerative cholitis
MedDRA version: 9.1Level: LLTClassification code 10038063Term: Rectal haemorrhage

Registration Number: EUCTR2006-003340-33-IT

Lead Sponsor: BRACCO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Both sex aged 18 years or more. Diagnosis of ulcerative rectocholitis with tenesmus and 4 unproductive fecal discharge or more. Patients with stable concomitant therapies for almost 1 month Informed consent obtained.
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who start a concomitant therapy Pregnancy or lactation Alcohol or drugs abuse Known allergy to mesalazine or nifedipine Non collaborative patients Patients who join any other study during the last month Any othe severe pathologies which can interfere with the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: evaluating the clinical efficacy of association mesalazine 1g nifedipine 10mg in 50 ml solution in patients suffering of distal ulcerative cholitis ulcerative rectosigmoiditis or proctitis with tenesmus;Secondary Objective: evaluating the effect of the association mesalazine 1g nifedipine 10 mg on its tolerability and on the Quality of Life of the patients;Primary end point(s): Complete risolution of symptom tenesmus within the fifth day of treatment visit 2 versus the basal number of daily fecal discharge

Secondary Outcome Measures