Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:February 2011
End Date:January 2014
Contact:Public Access to Clinical Trials - Novo Nordisk
Email:clinicaltrials@novonordisk.com
Phone:Please Contact NN via email

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A Randomised, Double-blind, Parallel-group, Placebo Controlled Induction Trial to Assess the Clinical Efficacy and Safety of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease


This trial is conducted in Europe and North America. The aim of the trial is to assess
disease activity and safety in subjects with moderately to severely active Crohn's disease
(CD) when treated with NNC 0142-0000-0002.


Inclusion Criteria:

- Subjects with CD for at least 3 months

- Subjects not treated before, or subjects who have either not responded to treatment,
or responded and then lost the response during continued administration of a
therapeutic compound

Exclusion Criteria:

- Any of the following: Symptomatic bowel obstruction, short bowel syndrome, ileostomy
or colostomy, surgical bowel resection within 6 months prior to randomisation or
clinically relevant un-drained abscess

- History of dysplasia or malignancy in the colon

- Any ongoing chronic or active infectious disease or microbial infection requiring
systemic oral or intravenous treatment against infection within 1 month prior to
randomisation

- Body mass index (BMI) higher or equal to 38.0 kg/m^2
We found this trial at
8
sites
Detroit, Michigan 48201
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Detroit, MI
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Arlington, Virginia 22201
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Arlington, VA
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Chicago, Illinois 60607
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Chicago, IL
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Erlanger, Kentucky 41018
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Erlanger, KY
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Hyattsville, Maryland 20782
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Hyattsville, MD
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Memphis, Tennessee 38163
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Memphis, TN
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Milwaukee, Wisconsin 53209
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Milwaukee, WI
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Morehead City, North Carolina 28557
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Morehead City, NC
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