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

NCT ID: NCT01654783

Last Updated: 2015-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5704 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-06-30

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)

Conditions

Ulcerative Colitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

5-ASA

Patient's treated with oral 5-ASA

No interventions assigned to this group

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyorin Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soji Omuro, Mr.

Role: STUDY_CHAIR

Kyorin Pharmaceutical Co.,Ltd

Locations

Tokyo Medical and Dental University

Bunkyo-ku, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 28390410 (View on PubMed)

Other Identifiers

OPTIMUM-2012

Identifier Type: -

Identifier Source: org_study_id