EUCTR2006-003340-33-IT
Active, Not Recruiting
N/A
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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tenesmus in patients with distal ulcerative cholitis
- Sponsor
- BRACCO
- Status
- Active, Not Recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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