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

NCT ID: NCT00572585

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-04-30

Brief Summary

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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

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Conditions

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Ulcerative Colitis

Keywords

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Ulcerative colitis immunosuppressive therapy AEB071 Modified Baron score Partial Mayo score

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AEB071

Group Type EXPERIMENTAL

AEB071

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AEB071

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Mobile, Alabama, United States

Site Status

Novartis Investigative Site

Mesa, Arizona, United States

Site Status

Novartis Investigative Site

Topeka, Kansas, United States

Site Status

Novartis Investigative Site

Lafayette, Louisiana, United States

Site Status

Novartis Investigative Site

Chesterfield Twp, Michigan, United States

Site Status

Novartis Investigative Site

Troy, Michigan, United States

Site Status

Novartis Investigative Site

Oklahoma City, Oklahoma, United States

Site Status

Novartis Investigative Site

Aarhus, , Denmark

Site Status

Novartis Investigative Site

Odense C, , Denmark

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Kiel, , Germany

Site Status

Novartis Investigative Site

Leipzig, , Germany

Site Status

Novartis Investigative Site

Lüneburg, , Germany

Site Status

Novartis Investigative Site

Minden, , Germany

Site Status

Novartis Investigative Site

Regensburg, , Germany

Site Status

Novartis Investigative Site

Stuttgart, , Germany

Site Status

Novartis Investigative Site

Krakow, , Poland

Site Status

Novartis Investigative Site

Poznan, , Poland

Site Status

Countries

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United States Denmark Germany Poland

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=8363

Results for CAEB071A2210 from the Novartis Clinical Trials website

Other Identifiers

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2007-002542-38

Identifier Type: -

Identifier Source: secondary_id

CAEB071A2210

Identifier Type: -

Identifier Source: org_study_id