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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyorin Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01654783
First received: July 30, 2012
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of relapses [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • The pUCDAI scores and the scores that constitute these pUCDAI scores at each assessment period [ Time Frame: 0, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Medication adherence:Measured by patient response to visual analog scale [ Time Frame: 0, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
5-ASA
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)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

University, Main hospital, General Hospital, General Practitioner

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654783

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

No publications provided

Responsible Party: Kyorin Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT01654783     History of Changes
Other Study ID Numbers: OPTIMUM-2012
Study First Received: July 30, 2012
Last Updated: July 22, 2014
Health Authority: Japan: Institutional Review Board

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

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014