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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01654783
Recruitment Status : Completed
First Posted : August 1, 2012
Last Update Posted : February 18, 2015
Information provided by (Responsible Party):
Kyorin Pharmaceutical Co.,Ltd

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.

Condition or disease
Ulcerative Colitis

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)

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Study Type : Observational
Actual Enrollment : 5704 participants
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
Study Start Date : September 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Patient's treated with oral 5-ASA

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01654783

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Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan, 113-8519
Sponsors and Collaborators
Kyorin Pharmaceutical Co.,Ltd
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Study Chair: Soji Omuro, Mr. Kyorin Pharmaceutical Co.,Ltd
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kyorin Pharmaceutical Co.,Ltd Identifier: NCT01654783    
Other Study ID Numbers: OPTIMUM-2012
First Posted: August 1, 2012    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015
Keywords provided by Kyorin Pharmaceutical Co.,Ltd:
5-ASA, ulcerative colitis, active, remission, adherence
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases