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Ulcerative ColitisNCT04499495

Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea

An observational study of Ulcerative Colitis, run by Ferring Pharmaceuticals at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The prevalence of ulcerative colitis (UC), which is one of the inflammatory bowel diseases, is known to be increasing and the majority of patients (≥ 85%) have experienced mild or moderate severity. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA)
Type of treatment
Pill or oral medicine
How many people
11,385 participants
Where
1 siteSouth Korea
Study dates
25 Oct 2021to 31 Jul 2022
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients will be selected from Korean HIRA claim database according to the inclusion/exclusion criteria. The Korean patients who were initially diagnosed with UC from 01 January 2009 to 30 June 2018 will be included in this study.

Who may be able to join

  • Patients who were diagnosed with UC during the index period.
  • Patients who had at least two claims of 5-ASA (sulfasalazine, balsalazide, mesalamine) during the index period.
  • Patients who underwent at least one endoscopy within a 3-month period prior to the index date (i.e. the first date of diagnosis with UC).
  • Defined as a claim with relevant endoscopy procedure code.
  • Include the upper gastrointestinal endoscopy, colonoscopy, sigmoidoscopy, which are identified using the procedure code.
  • Patients who were treated with 5-ASA continuously for at least 1-month after the index date.
  • Defined as those who were treated with 5-ASA for more than 30 days within 6-month after the index date (i.e. the first date of diagnosis with UC).

Who cannot join

  • Patients less than 15 years old as of the index date (<15 years old).
  • Patients who were treated with 5-ASA during the baseline period (i.e. 12-month prior to the index date).
  • Patients who were diagnosed with UC during the baseline period.
  • Patients who received steroids, immunosuppressants, or biologics during the baseline period.
  • Steroid includes both oral medication and intravenous (IV) injection. The analysis will include the moderate- to high-dose of cumulative steroid use, which is defined as >=30mg of prednisolone, >= 50mg of methylprednisolone, or >=50mg of hydrocortisone.
  • Immunosuppressants is defined as at least one claim with Azathioprine or 6-Mercaptopurine.
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  • Biologics is defined as at least one claim with Infliximab, Adalimumab, Ustekinumab, Vedolizumab, Golimumab, or Tofacitinib.
  • Patients who were diagnosed with Crohn's disease at any time in the overall study period.
  • Defined as a claim with relevant Crohn's disease code recorded as primary diagnosis during the baseline period or follow-up period (i.e. entire study period).

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital

    Seoul, Seodaemun-gu

Other trials in South Korea

About this study

Official title: A Retrospective Study to Assess 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea

The prevalence of ulcerative colitis (UC), which is one of the inflammatory bowel diseases, is known to be increasing and the majority of patients (≥ 85%) have experienced mild or moderate severity.

5-Aminosalicylic acid (5-ASA), immunomodulator, or biologics, etc are prescribed to treat UC, however 5-ASA is generally considered the first-line therapy. The recent UC treatment guideline in Korea and the United States/ European Union (US/EU) have recommended higher daily dose for patients with mild or moderate severity than the previous guidelines since 2017. Accordingly, it is assumed that the average daily treatment dose of 5-ASA would increase in patients who were initially diagnosed with UC in real-world clinical practice in Korea. However, there are not many studies evaluating the treatment patterns and health outcomes of 5-ASA based on the recent treatment guideline in South Korea.

This study, hence, aims to investigate the impact of changes in daily dose of 5-ASA on the treatment patterns and health outcomes such as recurrence rate, hospitalization rate, and surgery rate in real world practice using Health Insurance Review and Assessment (HIRA) claims database.

Being tested
PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA)
Keywords
Mesalamine, Retrospective, 5-aminosalicylic acid, Prescription pattern
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA)Other

    The 5-ASAs of interest in the study are mesalazine (5-ASA); sulfasalazine (5-ASA+sulfapyridine); and balsalazide (5-ASA) and will be grouped together as 5-ASA. For sulfasalazine and balsalazide, the equivalent dose to 5-ASA will be calculated as: balsalazide 6.75g is equivalent to 2.4g of mesalamine; and Sulfasalazine 4g is equivalent to 1.6g of mesalamine.

    The dose will be stratified by oral monotherapy, rectal monotherapy, oral and rectal combination therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in initial 3-months average daily dose of 5-ASA

    Initial average daily dose is defined as the average dose of 5-ASA prescribed over the 3-month period following the first prescription date of 5-ASA (i.e. prescription index date). Dose of 5-ASA includes those of mesalamine, sulfasalazine, and balsalazide.

    The dose will be stratified by oral monotherapy, rectal monotherapy, oral and rectal combination therapy. Oral and rectal combination therapy will be identified when the percentage of rectal therapy over the 3-months following the first prescription date of 5-ASA is more than 25%. For oral and rectal combination therapy, only oral formulation will be considered to calculate the dose of a combination therapy.

    The average daily dose of 5-ASA will be categorized as: Oral mono high dose (>=3g), oral mono standard dose (2-3g), oral mono low dose (<2g); Oral combination high dose (>=3g), oral combination standard dose (2-3g); oral combination low dose (<2g); Rectal monotherapy.

    Measured: From prescription index date up to 3 months

  2. Prescription patterns of 5-ASA

    The prescription patterns will be categorized into: oral monotherapy; rectal monotherapy; oral and rectal combination therapy based on the exposure medications (mesalazine, sulfasalazine, and/or balsalazide) prescribed.

    Measured: From 01 January 2009 to 31 March 2019

Secondary outcomes (3)

  1. Non-response to 5-ASA by the average daily dose of 5-ASA

    The non-response to 5-ASA is defined as: >=1 claims with international statistical classification of diseases 10th revision (ICD-10) code for UC as primary diagnosis and with pre-defined medications prescribed to those who are not responsive to 5-ASA. Medications for non-response are defined as add-on or switching to steroids, immunosuppressants, and/or biologics.

    Measured: From 01 January 2009 to 31 March 2019

  2. Ulcerative Colitis Related hospitalization by the average daily dose of 5-ASA

    The hospitalization is defined as: >=1 length of stay (days); admission to the department for gastroenterology; and at least one surgery code or UC medications. The UC surgery includes small bowel resection, colon resection, and/or low anterior resection, defined using surgery code. The UC medication is defined as moderate- to high-dose steroids, immunosuppressants, and/or biologics.

    Measured: From 01 January 2009 to 31 March 2019

  3. Ulcerative Colitis related surgery by the average daily dose of 5-ASA

    Surgeries include small bowel resection, colon resection, and/or low anterior resection, which will be identified using surgery code.

    Measured: From 01 January 2009 to 31 March 2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2020
  2. Study start25 Oct 2021
  3. Primary completion31 Jul 2022
  4. Study completion31 Jul 2022

Resources

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
Retrospective
Enrolment
11,385 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04499495
Sponsor's protocol ID
000388
Status last verified
May 2022
First submitted
31 Jul 2020
Last updated
10 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park SJ, Park SW, Cheon JH. Ten-Year Trend in 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients with Ulcerative Colitis: An Analysis of Korean Health Insurance Data. Dig Dis Sci. 2026 Jun;71(6):2218-2228. doi: 10.1007/s10620-025-09629-0. Epub 2025 Dec 23.

    PubMed 41436897

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by Ferring Pharmaceuticals at 1 site in South Korea.

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 7 inclusion and 9 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 10 Sep 2022. 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 South Korea. 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?

Changes in initial 3-months average daily dose of 5-ASA (time frame: From prescription index date up to 3 months). The study lists 2 primary outcomes in all. 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 NCT04499495, 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 10 Sep 2022.

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