A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS

• Conditions: Active Ulcerative Colitis Patients; MedDRA version: 14.1Level: LLTClassification code 10021184Term: IBDSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-003283-78-IT
• Lead Sponsor: GIULIANI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-01
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 < 6 weeks (score of 4 – 10 inclusive on the UC-DAI, with a sigmoidoscopy score of 2).
•Patients who have relapsed on maintenance therapy with 5-ASA doses of =2.4 gr/day for at least 3 months
•Out-patients of both sexes aging 18 and over years old.
•CMV Negative Test (at screening)
•Female patients not of childbearing potential (post menopausal – defined as one year post menopause – surgically or biologically sterile); female patients of childbearing potential upon negative urine pregnancy test at screening and using effective method of birth control during the studyand at least for 30 days after the administration of the study drug.
•Male patients who agree to use a condom throughout the duration of the study and for 30 days after the administration of the study drug.
•Ability, willingness and likeliness 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 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified