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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.
Register: EUCTR
Last refreshed on: 20 February 2017
Main ID:  EUCTR2004-004854-19-SK
Date of registration: 09/02/2005
Prospective Registration: Yes
Primary sponsor: Italfarmaco S.p.A.
Public title: A randomized, double-blind, placebo-controlled, parallel group multicenter study to investigate efficacy and safety of ITF 2357 in the management of patients with active moderate to severe Crohn’s disease
Scientific title: A randomized, double-blind, placebo-controlled, parallel group multicenter study to investigate efficacy and safety of ITF 2357 in the management of patients with active moderate to severe Crohn’s disease
Date of first enrolment: 25/04/2005
Target sample size: 50
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004854-19
Study type:  Interventional clinical trial of medicinal product
Study design:  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  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Slovakia
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
- Crohn’s disease with an endoscopical confirmation of ileocolitis or ileitis and a histological proof of activity within the previous 12 months
- Moderate to severe activity demonstrated by a CDAI score between 220 and 450
- Age >= 18 years
- Duration of disease activity: at least 3 months
- Disease uncontrolled by oral corticosteroids for at least 2 months
- Treatment with oral corticosteroids for at least 4 weeks on a stable dose equivalent to 40 mg/day of prednisone or less, or 9 mg/day of budesonide, with/without concomitant treatment with immunosuppressants
- If receiving immunosuppressants, the dose must have been stable for at least 8 weeks
- A CRP value equal to or greater than twice the upper laboratory norm (2XULN) as defined at each local laboratory
- Females with negative pregnancy test
- Signed written informed consent

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:
- Females of childbearing potential without using a safe contraceptive measure
- Treatment in the previous 6 months with cytokines or cytokine inhibitors
- Platelet counts below 200 x 109/L
- Acute or chronic infections
- Current bowel obstruction, intestinal perforation, significant GI hemorrhage
- Ostomy or extensive bowel resection
- Expected surgery
- History of cancer or tuberculosis
- Lactose intolerance



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)

Product Name: ITF2357
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ITF2357
Other descriptive name: Diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphtalen-2-ylmethyl]-ammonium chloride mon
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-100
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: To identify one or more effective doses of ITF 2357 in the management of Crohn’s disease suitable for further evaluation in phase III studies
Primary end point(s): The percent change in CRP value at week 8 compared to study day -1
Secondary Objective: To assess safety and tolerability of the 8-week oral treatment with ITF 2357
To investigate pharmacokinetics of the administered ITF 2357 doses
Secondary Outcome(s)
Secondary ID(s)
DSC/03/2357/06
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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