Clinical trial NCT01654783: Observational Study in the Management of Ulcerative Colitis With Oral 5-ASA
Official title: Observational Study on Clinical Practice in the Management of Ulcerative Colitis With Oral 5-Aminosalicylic Acid in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Keywords: 5-ASA, ulcerative colitis, active, remission, adherence
Lead sponsor: Kyorin Pharmaceutical Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2012-08-01
Enrollment: 5704
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: University, Main hospital, General Hospital, General Practitioner

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:

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)

Eligibility criteria: Inclusion Criteria:

1. Outpatients
2. Adult patients who have been diagnosed with mild to moderate active ulcerative colitis or ulcerative colitis in the remission stage according to the diagnostic criteria for ulcerative colitis (draft revised on February 13, 2010)
3. Patients who have been treated with remission induction therapy or remission maintenance therapy with oral 5-ASA drugs (Pentasa® tablets 250 mg, Pentasa® tablets 500 mg, Asacol® tablets 400 mg and Salazopyrin® tablets 500 mg as well as drugs that have been proved equivalent to these drugs)
4. Patients who have received adequate information regarding this study and understood thoroughly, and then voluntarily submitted written consent forms upon participation in this study

Exclusion Criteria:

1. Patients with severe active ulcerative / fulminant ulcerative colitis according to the diagnostic criteria for ulcerative colitis (draft revised on February 13, 2012)
2. Patients who have received total / subtotal colectomy
3. Patients who have been complicated with malignant tumor
4. Patients who are pregnant or possibly pregnant
5. Other patients whom investigators and subinvestigators considered inappropriate to participate in this study

Primary outcomes:
measure: Cumulative non-relapse rate
timeFrame: 52 weeks
Secondary outcomes:
measure: Number of relapses
timeFrame: 52 weeks
measure: The pUCDAI scores and the scores that constitute these pUCDAI scores at each assessment period
timeFrame: 0, 26 weeks, 52 weeks
measure: Medication adherence:Measured by patient response to visual analog scale
timeFrame: 0, 26 weeks, 52 weeks
Other outcomes:
Locations:
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University
state: Tokyo
Study officials:
affiliation: Kyorin Pharmaceutical Co.,Ltd
name: Soji Omuro, Mr.
role: STUDY_CHAIR
References:
citation: Nagahori M, Kochi S, Hanai H, Yamamoto T, Nakamura S, Omuro S, Watanabe M, Hibi T; OPTIMUM Study Group. Real life results in using 5-ASA for maintaining mild to moderate UC patients in Japan, a multi-center study, OPTIMUM Study. BMC Gastroenterol. 2017 Apr 4;17(1):47. doi: 10.1186/s12876-017-0604-y.