A phase II multi-center, randomized, double-blind, controlled vs placebo, long-term extension study to evaluate the safety and tolerability of 40 mg GED-0301for the maintainance of Crohn’s disease in remission.
- Conditions
- CROHN'S DISEASE IN REMISSION PHASEMedDRA version: 14.1Level: LLTClassification code 10021315Term: Ileitis terminalSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2011-005678-47-IT
- Lead Sponsor
- GIULIANI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1 Written informed consent, personally signed and dated by the patient prior any study-related procedures is carried out. 2 Patients in remission of Crohn’s disease at the end (Week 12) of the lead-in study.( I.G.O.N. 1 Study - Prot.GED-301-01-11) 3 Female patients not of childbearing potential (women in menopause defined as surgically sterile or one year postmenopausal); female patients of childbearing potential upon negative pregnancy testing at enrollement and using effective method of birth control during the study. 4 Ability to understand and comply with study procedures and restrictions.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
1. Pregnant or breast-feeding women. 2. Screening laboratory values within the following parameters: ? APTT > 1.5 ULN ? platelet count =100,000 /mm3 ? serum creatinine>1.5 ULN ? total bilirubin >1.5 ULN (excluding Gilbert Syndrome) ? AST and ALT >1.5 ULN. 3. QTc interval >450 msec for males and >470 msec for females 4. Any medical disorder emerged during/after the participation in IGON 1 that may require treatment (e.g. renal or hepatic impairment) or that make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of safety of GED-0301, oral administration in a long-term study.;Secondary Objective: Evaluation of efficacy of GED-0301 in the maintenance of Remission in patients with Crohn’s disease, defined as % of patients in remission (CDAI <150) at Week 16 and at Week 36;Primary end point(s): Evaluation of safety of GED-0301, oral administration in a long-term study.;Timepoint(s) of evaluation of this end point: Week 16 e Week 36
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Evaluation of efficacy of GED-0301 in the maintenance of Remission in patients with Crohn’s disease, defined as % of patients in remission (CDAI <150) at Week 16 and at Week 36;Timepoint(s) of evaluation of this end point: Week 16 and Week 36