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NCT00572585 Clinical Trial

Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:
A Randomized, Double Blind, Placebo Controlled, Parallel Group Design Study to Explore the Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00572585
Other study ID # CAEB071A2210
Secondary ID 2007-002542-38
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2010
Est. completion date April 2012

Study information
Verified date March 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the efficacy, safety and tolerability of AEB071 in the treatment of active, moderate to severe ulcerative colitis in patients who have failed conventional therapy using mesalamine or steroids

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 18-75 years males and females - Female subjects of childbearing potential must be using two methods of contraception - Active, moderate to severe disease - Poor response to or no toleration of conventional therapy (e.g. steroids, mesalamine) - Good communication with the investigator, understanding and compliance with the requirements of the study and written informed consent Exclusion Criteria: - Allergy to the drug - Very low or high body weight - Ongoing treatment with specific other medication (e.g. antibiotics) - Diagnosis of primary sclerosing cholangitis - Renal impairment - Toxic megacolon - Presence or history of specific other diseases, cancer, cardiac abnormalities, abnormal laboratory findings - History of alcohol or drug abuse - Pregnant or breastfeeding women - Positive HIV, Hepatitis B or Hepatitis C test result Other protocol-defined inclusion/exclusion criteria do apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AEB071

• Placebo

Locations
Country Name City State
Denmark Novartis Investigative Site Århus
Denmark Novartis Investigative Site Odense C
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Kiel
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Lüneburg
Germany Novartis Investigative Site Minden
Germany Novartis Investigative Site Regensburg
Germany Novartis Investigative Site Stuttgart
Poland Novartis Investigative Site Kraków
Poland Novartis Investigative Site Poznan
United States Novartis Investigative Site Chesterfield Twp Michigan
United States Novartis Investigative Site Lafayette Louisiana
United States Novartis Investigative Site Mesa Arizona
United States Novartis Investigative Site Mobile Alabama
United States Novartis Investigative Site Oklahoma City Oklahoma
United States Novartis Investigative Site Topeka Kansas
United States Novartis Investigative Site Troy Michigan

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Denmark,  Germany,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of induction of remission after 28 days of treatment (using the Partial Mayo Score and the Modified Baron Score), also an Endoscopic biopsy will be taken Partial Mayo Score throughout entire study, biopsy at end of dosing period
Secondary Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events) Throughout entire study
Secondary Measurement of drug concentrations in blood During the dosing period only
Secondary Relationship between drug concentration in blood and disease activity Dosing period only
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