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

Tracking Information

First Received Date ^ICMJE

December 12, 2007

Last Updated Date

July 15, 2008

Start Date ^ICMJE

July 2008

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

• Rate of induction of remission after 28 days of treatment (using the Partial Mayo Score and the Modified Baron Score) [ Time Frame: throughout the study ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00572585 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

• Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events) • Measurement of drug concentrations in blood • Relationship between drug concentration in blood and disease activi [ Time Frame: throughout the study ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Ulcerative Colitis

Intervention ^ICMJE

Drug: AEB071
Drug: Placebo

Study Arms / Comparison Groups

Experimental: AEB071A

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00572585

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CAEB071A2210

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

NOVARTIS

Novartis investigator site

Information Provided By

Novartis

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP