Observational Study in the Management of Ulcerative Colitis With Oral 5-ASA
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date ICMJE | July 30, 2012 | ||||||||
Last Updated Date | September 14, 2012 | ||||||||
Start Date ICMJE | September 2012 | ||||||||
Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Cumulative non-relapse rate [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01654783 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
Original Secondary Outcome Measures ICMJE |
|
||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Observational Study in the Management of Ulcerative Colitis With Oral 5-ASA | ||||||||
Official Title ICMJE | Observational Study on Clinical Practice in the Management of Ulcerative Colitis With Oral 5-Aminosalicylic Acid in Japan | ||||||||
Brief Summary | The objectives of this study are to investigate how oral 5-ASA drugs have been used in the condition without symptoms such as abdominal pain or diarrhea/bloody stool (remission stage), or in the transition from the condition with symptoms such as abdominal pain or diarrhea/bloody stool (active stage) to the remission stage in ulcerative colitis and to study how many patients will be able to maintain the remission stage during the observation period and how many times the patients will experience the active stage (relapse), as well as how symptoms will change during the observation period to discover better treatment plans. |
||||||||
Detailed Description | Period: 2012-2014 Observation Time: 0, 26week, 52week Matters investigated:
|
||||||||
Study Type ICMJE | Observational | ||||||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||||||
Biospecimen | |||||||||
Sampling Method | Probability Sample | ||||||||
Study Population | University, Main hospital, General Hospital, General Practitioner |
||||||||
Condition ICMJE | Ulcerative Colitis | ||||||||
Intervention ICMJE | |||||||||
Study Group/Cohort (s) | 5-ASA
Patient's treated with oral 5-ASA |
||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE | 5000 | ||||||||
Estimated Completion Date | June 2014 | ||||||||
Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Gender | Both | ||||||||
Ages | 20 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
|
||||||||
Location Countries ICMJE | Japan | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01654783 | ||||||||
Other Study ID Numbers ICMJE | OPTIMUM-2012 | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | Kyorin Pharmaceutical Co.,Ltd | ||||||||
Study Sponsor ICMJE | Kyorin Pharmaceutical Co.,Ltd | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
|
||||||||
Information Provided By | Kyorin Pharmaceutical Co.,Ltd | ||||||||
Verification Date | September 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |