Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT00572585 |
Date of registration:
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12/12/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis
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Scientific title:
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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 |
Date of first enrolment:
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April 2010 |
Target sample size:
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60 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00572585 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Denmark
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Germany
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Poland
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion 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
Other protocol-defined inclusion/exclusion criteria do apply
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Placebo
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Drug: AEB071
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Relationship between drug concentration in blood and disease activity
[Time Frame: Dosing period only]
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Measurement of drug concentrations in blood
[Time Frame: During the dosing period only]
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Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events)
[Time Frame: Throughout entire study]
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Secondary ID(s)
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2007-002542-38
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CAEB071A2210
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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