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 |
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
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