Observational Study in the Management of Ulcerative Colitis With Oral 5-ASA

Ulcerative Colitis Clinical Trial

Official title: Observational Study on Clinical Practice in the Management of Ulcerative Colitis With Oral 5-Aminosalicylic Acid in Japan

Status Completed

Clinical Trial 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.

Clinical Trial Description

Period: 2012-2014 Observation Time: 0, 26week, 52week

Matters investigated:

1. pUCDAI scores(Stool frequency, Bloody stool, Physician's global assessment)

2. Medication adherence (VAS scale)

3. Remission, Relapse

4. Age, gender, body height, body weight, date of diagnosis, extension of inflammation, classification by clinical course, smoking, alcohol, work, disease complication, duration of remission maintained to enrollment(remission patient) ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

• NCT number: NCT01654783
• Study type: Observational
• Source: Kyorin Pharmaceutical Co.,Ltd
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Completion date: June 2014