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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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21 December 2021 |
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Main ID: |
EUCTR2004-001677-26-HU |
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Date of registration:
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03/11/2004 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE
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Scientific title:
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Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE |
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Date of first enrolment:
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25/01/2005 |
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Target sample size:
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300 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001677-26 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Czech Republic
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Estonia
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Hungary
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Italy
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Spain
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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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:
- Pregnant or breastfeeding women.
- Chrön disease.
- Positive stool cultures.
- Treatment with methotrexate or cyclosporine or corticosteroïds over 20 mg/day of prednisolone.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0
Level: LLT
Classification code 10045365
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Intervention(s)
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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 unit: mg milligram(s)
Concentration type: equal
Concentration number: 200--of active moiety
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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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.
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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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Secondary Objective: Efficacy of SR140333B on pain reduction.
Endoscopical and histological effect of SR140333B.
Safety of SR140333B.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 01/12/2004
Contact:
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