Ulcerative ColitisNCT01654783
Observational Study in the Management of Ulcerative Colitis With Oral 5-ASA
An observational study of Ulcerative Colitis, run by Kyorin Pharmaceutical Co.,Ltd at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ulcerative Colitis
- Type of treatment
- Pill or oral medicine
- How many people
- 5,704 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: University, Main hospital, General Hospital, General Practitioner
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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)
- Conditions
- Ulcerative Colitis
- Keywords
- 5-ASA, ulcerative colitis, active, remission, adherence
- Medical subject headings
- Colitis, Ulcerative, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 5-ASA | Patient's treated with oral 5-ASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative non-relapse rate
Measured: 52 weeks
Secondary outcomes (3)
Number of relapses
Measured: 52 weeks
The pUCDAI scores and the scores that constitute these pUCDAI scores at each assessment period
Measured: 0, 26 weeks, 52 weeks
Medication adherence:Measured by patient response to visual analog scale
Measured: 0, 26 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,704 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Soji Omuro, Mr., Study chair, Kyorin Pharmaceutical Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654783
- Sponsor's protocol ID
- OPTIMUM-2012
- Status last verified
- Feb 2015
- First submitted
- 30 Jul 2012
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nagahori M, Kochi S, Hanai H, Yamamoto T, Nakamura S, Omuro S, Watanabe M, Hibi T; OPTIMUM Study Group. Real life results in using 5-ASA for maintaining mild to moderate UC patients in Japan, a multi-center study, OPTIMUM Study. BMC Gastroenterol. 2017 Apr 4;17(1):47. doi: 10.1186/s12876-017-0604-y.
PubMed 28390410
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Clinical Practice in the Management of Ulcerative Colitis With Oral 5-Aminosalicylic Acid in Japan
- ClinicalTrials.gov ID
- NCT01654783
- Acronym / sponsor ID
- OPTIMUM-2012
- Conditions
- Ulcerative Colitis
- Keywords
- 5-ASA, ulcerative colitis, active, remission, adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,704 participants (actual)
- Lead sponsor
- Kyorin Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5-ASA | – | –Patient's treated with oral 5-ASA |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University, Main hospital, General Hospital, General Practitioner
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative non-relapse rate
Time frame: 52 weeks
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- Derived from this study: PubMed 28390410Nagahori M, Kochi S, Hanai H, Yamamoto T, Nakamura S, Omuro S, Watanabe M, Hibi T; OPTIMUM Study Group. Real life results in using 5-ASA for maintaining mild to moderate UC patients in Japan, a multi-center study, OPTIMUM Study. BMC Gastroenterol. 2017 Apr 4;17(1):47. doi: 10.1186/s12876-017-0604-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soji Omuro, Mr. study chair
Kyorin Pharmaceutical Co.,Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Kyorin Pharmaceutical Co.,Ltd at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative non-relapse rate (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01654783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.