Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT00209300
Brief Summary:
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.
Study:
NCT00209300
Study Brief:
Protocol Section:
NCT00209300