Colitis, UlcerativeNCT02537210
Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis
A study testing Mesalazine in people with Colitis, Ulcerative and Aminosalicylic Acid, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Ulcerative, Aminosalicylic Acid
- What is being tested?
- Mesalazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2015to 10 Sep 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a confirmed diagnosis of UC according to established clinical, endoscopic and histologic criteria
- in long-standing clinical remission
- written informed consent
Who cannot join
- allergic to mesalazine
- prior bowel surgery except appendectomy
- hepatic or renal dysfunction
- malignant disease within 5 years
- pregnancy or breast feeding or women of child-bearing age without regular use of contraception
- on anti-tumor necrosis factor therapy
- terminal illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral 5-aminosalicylic Acid Withdrawal in Long Standing Inactive Ulcerative Colitis: A Double-blind, Randomized, Placebo-controlled Trial
The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.
Read the detailed description
This is a randomized, double-blind, controlled trial in which patients with long-standing clinically inactive UC receiving ASA for maintenance of remission will be randomized to either continue 5-ASA or to receive an equivalent placebo for 12 months. The primary endpoint is clinical relapse at 12 months.
- Conditions
- Colitis, Ulcerative, Aminosalicylic Acid
- Being tested
- Mesalazine, Placebo oral capsule
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalazineDrug
Also called Asacol
Patients will be prescribed Asacol 2g daily for 12 months
Placebo oral capsuleDrug
Also called Placebo
Patients will be prescribed placebo 5 capsules daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Mesalazine | Active comparator | mesalazine 2g od po for 12 months Receives: Drug: Mesalazine |
| Placebo oral capsule | Placebo comparator | placebo 5 capsules od po for 12 months Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences of relapse rates between the two arms
Relapse rate of patient in both arms will be calculated
Measured: 12 months
Secondary outcomes (1)
Patients' drug compliance
Proportion of patients with good drug compliance, defined as more than 80% of drug taken will be evaluated.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Elizabeth Hospital, Hong Kong, Alice Ho Miu Ling Nethersole Hospital, Tseung Kwan O Hospital, Hong Kong
- Responsible party
- Principal investigator, Siew Chien NG, Chinese University of Hong Kong
- Investigators
- Siew Ng, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537210
- Sponsor's protocol ID
- ASA withdrawal study
- Status last verified
- May 2023
- First submitted
- 28 Aug 2015
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral 5-aminosalicylic Acid Withdrawal in Long Standing Inactive Ulcerative Colitis: A Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02537210
- Acronym / sponsor ID
- ASA withdrawal study
- Conditions
- Colitis, Ulcerative, Aminosalicylic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Elizabeth Hospital, Hong Kong, Alice Ho Miu Ling Nethersole Hospital, Tseung Kwan O Hospital, Hong Kong
- Study start
- Sep 2015 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 1 Sep 2015 (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 purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.
Detailed description
This is a randomized, double-blind, controlled trial in which patients with long-standing clinically inactive UC receiving ASA for maintenance of remission will be randomized to either continue 5-ASA or to receive an equivalent placebo for 12 months. The primary endpoint is clinical relapse at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesalazine | Active comparator | Drug: Mesalazinemesalazine 2g od po for 12 months |
| Placebo oral capsule | Placebo comparator | Drug: Placebo oral capsuleplacebo 5 capsules od po for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- have a confirmed diagnosis of UC according to established clinical, endoscopic and histologic criteria
- in long-standing clinical remission
- written informed consent
Key exclusion criteria (7 listed)
- allergic to mesalazine
- prior bowel surgery except appendectomy
- hepatic or renal dysfunction
- malignant disease within 5 years
- pregnancy or breast feeding or women of child-bearing age without regular use of contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MesalazineAlso: AsacolPatients will be prescribed Asacol 2g daily for 12 months | Drug | Mesalazine |
| Placebo oral capsuleAlso: PlaceboPatients will be prescribed placebo 5 capsules daily for 12 months | Drug | Placebo oral capsule |
Primary outcome
The differences of relapse rates between the two arms
Time frame: 12 months
Relapse rate of patient in both arms will be calculated
1 secondary outcome
Patients' drug compliance
Time frame: 12 months
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 31 May 2023.
- Individual participant dataSharing planned: No
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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.
Siew Ng, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesalazine in people with Colitis, Ulcerative and Aminosalicylic Acid, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 7 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 31 May 2023. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
The differences of relapse rates between the two arms (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2023.