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

This study is not yet open for participant recruitment.
Verified September 2012 by Kyorin Pharmaceutical Co.,Ltd
Sponsor:
Information provided by (Responsible Party):
Kyorin Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01654783
First received: July 30, 2012
Last updated: September 14, 2012
Last verified: September 2012

July 30, 2012
September 14, 2012
September 2012
June 2014   (final data collection date for primary outcome measure)
Cumulative non-relapse rate [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01654783 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 [ Time Frame: 0, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
 
 
 
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

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.

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)
Observational
Observational Model: Cohort
Time Perspective: Prospective
 
Probability Sample

University, Main hospital, General Hospital, General Practitioner

Ulcerative Colitis
 
5-ASA
Patient's treated with oral 5-ASA
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
5000
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Akito Saegusa, Mr. 81-3-3293-3422 akito.saegusa@mb.kyorin-pharm.co.jp
Contact: Shigehisa Hara, Mr. 81-3-3293-3422 shigehisa.hara@mb.kyorin-phaem.co.jp
Japan
 
NCT01654783
OPTIMUM-2012
No
Kyorin Pharmaceutical Co.,Ltd
Kyorin Pharmaceutical Co.,Ltd
 
Study Chair: Akito Saegusa, Mr. Kyorin Pharmaceutical Co.,Ltd
Kyorin Pharmaceutical Co.,Ltd
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP