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

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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis

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)

• Study Type: Observational
• Enrollment (Actual): 5704

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Tokyo Medical and Dental University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

University, Main hospital, General Hospital, General Practitioner

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
5-ASA; Patient's treated with oral 5-ASA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative non-relapse rate	52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of relapses	52 weeks
The pUCDAI scores and the scores that constitute these pUCDAI scores at each assessment period	0, 26 weeks, 52 weeks
Medication adherence:Measured by patient response to visual analog scale	0, 26 weeks, 52 weeks

Collaborators and Investigators

• Sponsor: Kyorin Pharmaceutical Co.,Ltd
• Investigators: Study Chair: Soji Omuro, Mr., Kyorin Pharmaceutical Co.,Ltd

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: July 30, 2012
• First Submitted That Met QC Criteria: July 30, 2012
• First Posted (Estimate): August 1, 2012

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 17, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: 5-ASA, ulcerative colitis, active, remission, adherence
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: OPTIMUM-2012