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

Completed · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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

Key facts

Study ID

NCT00572585

Run by

Novartis Pharmaceuticals

People needed

60

Starts

2010-04-01

Expected to finish

2012-04-01

Last updated by the study team

2020-12-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Mobile, Alabama, United States
• Novartis Investigative Site — Mesa, Arizona, United States
• Novartis Investigative Site — Topeka, Kansas, United States
• Novartis Investigative Site — Lafayette, Louisiana, United States
• Novartis Investigative Site — Chesterfield Twp, Michigan, United States
• Novartis Investigative Site — Troy, Michigan, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Aarhus, Denmark
• Novartis Investigative Site — Odense C, Denmark
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Hanover, 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, Germany
• Novartis Investigative Site — Krakow, Poland
• Novartis Investigative Site — Poznan, Poland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.