A Study of Pentasa in Patients With Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01104753
First received: March 26, 2010
Last updated: April 6, 2011
Last verified: April 2011

March 26, 2010
April 6, 2011
September 2009
October 2010   (final data collection date for primary outcome measure)
Verify the safety profile [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Number of AEs/SAEs
  • Intensity and seriousness of reported AEs/SAEs
Same as current
Complete list of historical versions of study NCT01104753 on ClinicalTrials.gov Archive Site
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A Study of Pentasa in Patients With Ulcerative Colitis
Non-interventional Post Marketing Safety Study Confirming Efficacy and Safety of Pentasa Slow Release Tablets in Patients With Ulcerative Colitis in Common Clinical Practice

Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).

Not Provided
Observational
Time Perspective: Prospective
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Non-Probability Sample

Patients suffering from ulcerative colitis

Ulcerative Colitis
Not Provided
Non-interventional post-authorisation safety study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
338
March 2011
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients suffering from ulcerative colitis

Exclusion Criteria:

  • Hypersensitivity to mesalazine, salicylates or to any excipient
  • Severe damage to liver or renal functions
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01104753
FE999907 CS07
No
Clinical Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP