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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: AEB 071

U.S. FDA Resources

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

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CAEB071A2210
Study First Received:	December 12, 2007
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00572585 History of Changes
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

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases

Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

ClinicalTrials.gov processed this record on March 18, 2010