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

Purpose

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

Condition	Intervention	Phase
Ulcerative Colitis	Drug: AEB071 Drug: Placebo	Phase II

Genetics Home Reference related topics:

Crohn disease

MedlinePlus related topics:

Ulcerative Colitis

U.S. FDA Resources

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

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

Further study details as provided by Novartis:

Primary Outcome Measures:

• 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 ]

Secondary Outcome Measures:

• 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 ]

Estimated Enrollment:	70
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Experimental AEB071A	Drug: AEB071
2: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572585

Locations


Germany
	Novartis Investigator Site
	Berlin, Germany

Sponsors and Collaborators

Novartis

Investigators


Principal Investigator:	NOVARTIS	Novartis investigator site

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CAEB071A2210
First Received:	December 12, 2007
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00572585
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency

Keywords provided by Novartis:

Ulcerative colitis, immunosuppressive therapy, AEB071, Modified Baron score, Partial Mayo score

Study placed in the following topic categories:

Digestive System Diseases

Gastrointestinal Diseases

Ulcer

Colonic Diseases

Inflammatory Bowel Diseases

Colitis, Ulcerative

Intestinal Diseases

Gastroenteritis

Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00572585