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

NCT01654783 | Completed

• 1 other identifier: OPTIMUM-2012
• Study Type: observational
• Target: 5,704
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

5-ASA, ulcerative colitis, active, remission, adherence

Outcome Measures

Primary Outcomes (1)

• Cumulative non-relapse rate

  52 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

5-ASA

Patient's treated with oral 5-ASA

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

University, Main hospital, General Hospital, General Practitioner

You may qualify if:

• Outpatients
• 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)
• 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)
• Patients who have received adequate information regarding this study and understood thoroughly, and then voluntarily submitted written consent forms upon participation in this study

You may not qualify if:

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

Sponsors & Collaborators

• Kyorin Pharmaceutical Co.,Ltd: lead

Study Sites (1)

Tokyo Medical and Dental University

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Related Publications (1)

• 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.

  PMID: 28390410 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Motor Activity

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Behavior

Study Officials

• Soji Omuro, Mr.

  Kyorin Pharmaceutical Co.,Ltd

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 1, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 18, 2015

Record last verified: 2015-02

Locations

JP (1)