Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001677-26-HU

Enrollment

300

Registered

2004-11-03

Start date

2005-01-25

Completion date

Unknown

Last updated

2021-12-21

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

Conditions

Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0 Level: LLT Classification code 10045365

Interventions

Product Name: Nolpitantium besylate Product Code: SR140333B Pharmaceutical Form: Tablet INN or Proposed INN: Nolpitantium besylate CAS Number: 155418-06-7 Current Sponsor code: SR140333B Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female patients of at least 18 years old, with Ulcerative Colitis, of at least 6 months duration, that are 5-aminosalicylic acid or sulphasalazine resistant defined as a Disease Activity Index of the Mayo Score included in [6-10], despite a 4 weeks treatment of 5-ASA or sulphasalazine (at least 2 g/day). 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: - Pregnant or breastfeeding women. - Chrön disease. - Positive stool cultures. - Treatment with methotrexate or cyclosporine or corticosteroïds over 20 mg/day of prednisolone.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy and clinical symptoms of two doses (1800 mg and 600 mg) of SR140333B, in patients with mild to moderate treatment [5-aminosalicylic acid (5-ASA) or sulphasalazine] resistant, Ulcerative Colitis, on top of this treatment compared to placebo.;Secondary Objective: Efficacy of SR140333B on pain reduction. Endoscopical and histological effect of SR140333B. Safety of SR140333B.;Primary end point(s): Clinical remission at 8 weeks defined as a Cinical Mayo score = 1 with no bleeding, with no initiation of rescue therapy for lack of efficacy (such as introduction or dose increase of corticoids, 5-ASA compounds or immuno-suppressant therapy).	—

Measure

Time frame

Main Objective: To evaluate the efficacy and clinical symptoms of two doses (1800 mg and 600 mg) of SR140333B, in patients with mild to moderate treatment [5-aminosalicylic acid (5-ASA) or sulphasalazine] resistant, Ulcerative Colitis, on top of this treatment compared to placebo.;Secondary Objective: Efficacy of SR140333B on pain reduction. Endoscopical and histological effect of SR140333B. Safety of SR140333B.;Primary end point(s): Clinical remission at 8 weeks defined as a Cinical Mayo score = 1 with no bleeding, with no initiation of rescue therapy for lack of efficacy (such as introduction or dose increase of corticoids, 5-ASA compounds or immuno-suppressant therapy).

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Countries

Czech Republic, Estonia, Hungary, Italy, Spain, Sweden

Outcome results

None listed

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