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 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), also an Endoscopic biopsy will be taken. [ Time Frame: Partial Mayo Score throughout entire study, biopsy at end of dosing period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events) [ Time Frame: Throughout entire study ] [ Designated as safety issue: Yes ]
Measurement of drug concentrations in blood [ Time Frame: During the dosing period only ] [ Designated as safety issue: No ]
Relationship between drug concentration in blood and disease activity [ Time Frame: Dosing period only ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	April 2010
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Novartis Pharmaceuticals

(001) 862 778 8300

Locations

United States, Arizona
Clinical Research Advantage	Recruiting
Mesa, Arizona, United States, 85206
Horizon Research Group	Recruiting
Mobile, Arizona, United States, 36608
United States, California
Discovery Clinical Research, 700 Garden View Court, Suite #201-F	Not yet recruiting
Encinitas, California, United States
United States, Connecticut
Connecticut Gastrology Consultants	Not yet recruiting
Hamden, Connecticut, United States, 06518
United States, Georgia
Digestive Care Associates	Not yet recruiting
Newnan, Georgia, United States, 30263
United States, Kansas
Cotton O'Neil Clinical Research	Recruiting
Topeka, Kansas, United States, 66606
United States, Louisiana
Horizon Research	Recruiting
Layfayette, Louisiana, United States, 70501
United States, Michigan
Clinical Research Institute of Michigan,	Not yet recruiting
Chesterfield, Michigan, United States, 48098
Center for Digestive Health	Recruiting
Troy, Michigan, United States, 48047
United States, Oklahoma
Oklahoma Foundation for Digestive Research	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Denmark
Novartis Investigative Site	Recruiting
Arhus, Denmark
Novartis Investigative Site	Withdrawn
Herlev, Denmark
Novartis Investigative Site	Not yet recruiting
Koge, Denmark
Novartis Investigative Site	Recruiting
Odense, Denmark
Germany
Novartis Investigative Site	Recruiting
Berlin, Germany
Novartis Investigative Site	Recruiting
Hamburg, Germany
Novartis Investigative Site	Not yet recruiting
Hannover, Germany
Novartis Investigative Site	Recruiting
Kiel, Germany
Novartis Investigative Site	Not yet recruiting
Leipzig, Germany
Novartis Investigative Site	Not yet recruiting
Minden, Germany
Novartis Investigative Site	Not yet recruiting
Regensburg, Germany
Novartis Investigative Site	Not yet recruiting
Stuttgart, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00572585 History of Changes
Other Study ID Numbers:	CAEB071A2210
Study First Received:	December 12, 2007
Last Updated:	May 12, 2011
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:

Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases

Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 13, 2012