Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission
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|ClinicalTrials.gov Identifier: NCT00209300|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 19, 2011
This is a multi-centre, randomised, controlled, investigator blinded study. The randomisation will be done centrally. The patients will be treated for 1 year, with clinical and laboratory assessments at 0, 4, 8 and 12 months.
Endoscopic examination is at enrollment and on completion of the study (at relapse or after 12 months).
Number of Subjects (Planned and Analysed):
- 360 patients for demonstration of non-inferiority between once daily and twice daily;
- 326 to be analysed in per-protocol (PP) analyses; and
- 360 in intention-to-treat (ITT) analyses.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: Pentasa||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||362 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission. A European Multi-centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Grams Once Daily|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||June 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209300
|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|