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Clinical Trials/EUCTR2012-002432-93-HU
EUCTR2012-002432-93-HU
Active, not recruiting
Not Applicable

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease

ovo Nordisk A/S0 sites114 target enrollmentSeptember 25, 2012
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ConditionsCrohns diseaseMedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Crohns disease
Sponsor
ovo Nordisk A/S
Enrollment
114
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 25, 2012
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Moderately to severely active Crohn’s disease, defined as a CDAI of 220\-450 (both inclusive) at Visit 2 (Dosing), with evidence of inflammation confirmed by a C\-reactive protein (CRP) \=10 mg/L or endoscopic verification (according to endoscopy imaging manual) performed at Visit 1 (Screening).
  • •\- Men and women between \=18 and \=75 years of age
  • •\- Biologic\-naïve subjects or biologic\-experienced for the treatment of Crohn’s disease. Biologic\-experienced subjects are eligible if they have not failed more than one marketed biologic therapy for the treatment of Crohn’s disease due to lack of efficacy (primary or secondary efficacy failures).
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 102
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 12

Exclusion Criteria

  • •\- Body mass index (BMI) \=38\.0 kg/m^2
  • •\- Any of the following: symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation, total colectomy or subtotal colectomy with less than 20 cm colon remaining, any abscesses not adequately treated
  • •\- History of dysplasia in the colon

Outcomes

Primary Outcomes

Not specified

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