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Completed

NCT Number: NCT01654783

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokyo Medical and Dental University

Bunkyo-ku, Tokyo, 113-8519, Japan

About this study

Period: 2012-2014 Observation Time: 0, 26week, 52week

Matters investigated:

  • pUCDAI scores(Stool frequency, Bloody stool, Physician's global assessment)
  • Medication adherence (VAS scale)
  • Remission, Relapse
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients
  • 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)
  • 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)
  • 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

  • Patients with severe active ulcerative / fulminant ulcerative colitis according to the diagnostic criteria for ulcerative colitis (draft revised on February 13, 2012)
  • Patients who have received total / subtotal colectomy
  • Patients who have been complicated with malignant tumor
  • Patients who are pregnant or possibly pregnant
  • Other patients whom investigators and subinvestigators considered inappropriate to participate in this study

Treatment and study plan

Primary outcomes

  1. Cumulative non-relapse rate

    Time frame: 52 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kyorin Pharmaceutical Co.,Ltd

Industry

Registry information

Official study title

Observational Study on Clinical Practice in the Management of Ulcerative Colitis With Oral 5-Aminosalicylic Acid in Japan

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 1, 2012
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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