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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654783
• Other study ID #: OPTIMUM-2012
• Status: Completed
• Phase: N/A
• First received: July 30, 2012
• Last updated: February 17, 2015
• Start date: September 2012
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: Kyorin Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5704
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
Japan	Tokyo Medical and Dental University	Bunkyo-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyorin Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative non-relapse rate		52 weeks	No
Secondary	Number of relapses		52 weeks	No
Secondary	The pUCDAI scores and the scores that constitute these pUCDAI scores at each assessment period		0, 26 weeks, 52 weeks	No
Secondary	Medication adherence:Measured by patient response to visual analog scale		0, 26 weeks, 52 weeks	No