Active Ulcerative Colitis Patients MedDRA version: 14.1 Level: LLT Classification code 10021184 Term: IBD System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: NA
Product Code: GED-0507-34-Levo
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: (-)-3-(4-Aminophenyl)-2-methoxypropionic acid
CAS Number: NA
Current Sponsor code: GE
Sponsors
GIULIANI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent, personally signed and dated by the patient prior any study-related procedures is carried out, ie before inclusion. • Patients must have a relapsing ulcerative colitis for =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Pregnant or breast-feeding women. • Patients with relapsing ulcerative colitis who have been in relapse for > 6 weeks. • Patients who have relapsed on maintenance therapy with doses of 5-ASA < 2.4 g/day. • Patients with proctitis (extent of inflammation = 15 cm), previous colonic surgery, Crohn’s disease, immediate risk of toxic megacolon or a stool culture positive for enteric pathogen. • The use of systemic or rectal steroids or rectal 5-ASA within the last 4 weeks • The use of immunosuppressants within the last 6 weeks • Antibiotic use within 7 days prior to the Baseline Visit will exclude patients. • Use prescription or non-prescription drugs, vitamins, or dietary supplements and herbal OTC products within 7 days prior to the administration of study drug • CMV Positive Test at screening • Patients having a disease or condition or any finding in his medical history, physical examination or clinical laboratory tests giving reasonable suspicion of a disease, which in the opinion of the investigator, may put the patients at risk because of participation in the study or may influence either the results of the study or the patient’s ability to participate in the study, • Patients with a history of drug or alcohol abuse. • Patients with a history of hypersensitivity to at least one ingredient of the test product. • Patients not able to understand information and give informed consent, or potentially presenting poor reliability (e.g. bad mental conditions). • Patients who used another investigational agent or who took part in a clinical trial within the last 6 months prior first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the percentage of patients that show clinical improvement (drop in UC DAI = 3 points from baseline to 8 weeks of treatment). To evaluate the change in UC-DAI score from baseline to 8 weeks of treatment. To evaluate the change in symptoms (rectal bleeding and stool frequency) from Baseline to 2, 4 and 8 Weeks. To evaluate the change in sigmoidoscopic (mucosal) appearance from baseline to 8 weeks of treatment;Primary end point(s): Percentage of patients in remission (defined as patients with UC-DAI score =1 with a score of 0 for rectal bleeding and stool frequency and at least a 1 point reduction from baseline in the sigmoidoscopy score) at Week 8 (after 8 weeks of study drug treatment).;Timepoint(s) of evaluation of this end point: At 8 weeks, end of tretament period;Main Objective: To evaluate the efficacy of GED-0507-34-Levo in patients with active ulcerative colitis defined as the percentage of patients in remission at Week 8 (after 8 weeks of treatment). The Remission is defined as Ulcerative Colitis Disease Activity Index (UC-DAI)= 1 with a score of 0 for rectal bleeding and stool frequency and at least a 1 point reduction from Baseline in the sigmoidoscopy score. To assess the safety and tolerability of GED-0507-34-Levo 160 mg/day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): percentage of patients who show a clinical improvement (drop in UC DAI = 3 points from baseline). •change in UC-DAI score from baseline to 8 weeks of treatment. •change in symptoms (rectal bleeding and stool frequency) from baseline to 2, 4 and 8 weeks. •change in sigmoidoscopic (mucosal) appearance from baseline to 8 weeks of treatment. •safety and tolerability;Timepoint(s) of evaluation of this end point: at 2, 4 and 8 weeks | — |
Countries
Italy
Contacts
Public ContactDIREZIONE ETICA
GIULIANI S.P.A.
Outcome results
None listed