CROHN'S DISEASE IN REMISSION PHASE MedDRA version: 14.1 Level: LLT Classification code 10021315 Term: Ileitis terminal System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: GED-0301
Product Code: NA
Pharmaceutical Form: Modified-release capsule, hard
Current Sponsor code: GED-0301
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentr
Sponsors
GIULIANI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactPHARMA DIVISION
GIULIANI SPA
Outcome results
None listed