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

This study has been completed.
Information provided by (Responsible Party):
Kyorin Pharmaceutical Co.,Ltd Identifier:
First received: July 30, 2012
Last updated: February 17, 2015
Last verified: February 2015
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.

Ulcerative Colitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on Clinical Practice in the Management of Ulcerative Colitis With Oral 5-Aminosalicylic Acid in Japan

Resource links provided by NLM:

Further study details as provided by Kyorin Pharmaceutical Co.,Ltd:

Primary Outcome Measures:
  • Cumulative non-relapse rate [ Time Frame: 52 weeks ]

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

Enrollment: 5704
Study Start Date: September 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Patient's treated with oral 5-ASA

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)

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
University, Main hospital, General Hospital, General Practitioner

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
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Please refer to this study by its identifier: NCT01654783

Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan, 113-8519
Sponsors and Collaborators
Kyorin Pharmaceutical Co.,Ltd
Study Chair: Soji Omuro, Mr. Kyorin Pharmaceutical Co.,Ltd
  More Information

Responsible Party: Kyorin Pharmaceutical Co.,Ltd Identifier: NCT01654783     History of Changes
Other Study ID Numbers: OPTIMUM-2012
Study First Received: July 30, 2012
Last Updated: February 17, 2015

Keywords provided by Kyorin Pharmaceutical Co.,Ltd:
5-ASA, ulcerative colitis, active, remission, adherence

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases processed this record on May 25, 2017