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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-003340-33-IT
Enrollment
Unknown
Registered
2007-03-09
Start date
2006-12-21
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Pharmaceutical Form: Rectal solution INN or Proposed INN: Mesalazine Concentration unit: g gram(s) Concentration type: equal Concentration number: 1- Product Name: nifedipine Pharmaceutical Form: Rec

Sponsors

BRACCO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026