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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01654783

Enrollment

5704

Registered

2012-08-01

Start date

2012-09-30

Completion date

2014-06-30

Last updated

2015-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

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

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Cumulative non-relapse rate	52 weeks

Secondary

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

Countries

Japan

Outcome results