Ulcerative Colitis in RemissionPhase 3NCT01257399
Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase
A Phase 3 study testing Asacol® and Mesalazine in people with Ulcerative Colitis in Remission, run by Tillotts Pharma AG at 1 site in China.
Trial summary
To demonstrate that import Mesalazine (ASACOL®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (rate of non-emergence of bloody stool), in patients with Ulcerative Colitis in remission, treated for 48 weeks. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Ulcerative Colitis in Remission
- What is being tested?
- Asacol® and Mesalazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Mar 2013
- Phase
- Phase 3
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with ulcerative colitis in remission who are defined to show an Ulcerative Colitis-Disease Activity Index (UC-DAI) score of 2 or less and a bloody stool score of 0.
Who cannot join
- Patients who take adrenal corticosteroid (oral formulation, enemas, suppository, agents for hemorrhoidal disease, injectable solution) within 14 days before start of administration of clinical study drug.
Trial locations and contacts
1 site in 1 country.
About this study
To demonstrate that import Mesalazine (ASACOL®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (rate of non-emergence of bloody stool), in patients with Ulcerative Colitis in remission, treated for 48 weeks.
- Conditions
- Ulcerative Colitis in Remission
- Being tested
- Asacol®, Mesalazine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asacol®Drug
Also called Import Mesalazine
400 mg tablets
MesalazineDrug
Also called Marketed Mesalazine
400mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Asacol® | Experimental | Import Mesalazine Receives: Drug: Asacol® |
| Mesalazine | Active comparator | Marketed Mesalazine Receives: Drug: Mesalazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of non-emergence of bloody stool
Measured: Week 48
Secondary outcomes (1)
1) Period of non-emergence of bloody stool, 2) Rate of non-recurrence, 3) Period of non-recurrence, 4) Reduction of UC-DAI score
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2013
- Study completionMar 2013
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 Colitis in RemissionStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tillotts Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zeria Pharmaceutical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257399
- Sponsor's protocol ID
- 03010302A
- Other IDs
- 2007L03525
- Status last verified
- Apr 2013
- First submitted
- 8 Dec 2010
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sun J, Yuan Y. Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Remission Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study. Adv Ther. 2016 Mar;33(3):410-22. doi: 10.1007/s12325-016-0304-y. Epub 2016 Feb 23.
PubMed 26905266
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase
- ClinicalTrials.gov ID
- NCT01257399
- Acronym / sponsor ID
- 03010302A
- Conditions
- Ulcerative Colitis in Remission
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Tillotts Pharma AGIndustry (pharma, biotech, devices)
- Collaborators
- Zeria Pharmaceutical
- Study start
- Nov 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 Dec 2010 (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.
To demonstrate that import Mesalazine (ASACOL®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (rate of non-emergence of bloody stool), in patients with Ulcerative Colitis in remission, treated for 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asacol® | Experimental | Drug: Asacol®Import Mesalazine |
| Mesalazine | Active comparator | Drug: MesalazineMarketed Mesalazine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with ulcerative colitis in remission who are defined to show an Ulcerative Colitis-Disease Activity Index (UC-DAI) score of 2 or less and a bloody stool score of 0.
Key exclusion criteria (1 listed)
- Patients who take adrenal corticosteroid (oral formulation, enemas, suppository, agents for hemorrhoidal disease, injectable solution) within 14 days before start of administration of clinical study drug.
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 |
|---|---|---|
| Asacol®Also: Import Mesalazine400 mg tablets | Drug | Asacol® |
| MesalazineAlso: Marketed Mesalazine400mg tablets | Drug | Mesalazine |
Primary outcome
Rate of non-emergence of bloody stool
Time frame: Week 48
1 secondary outcome
1) Period of non-emergence of bloody stool, 2) Rate of non-recurrence, 3) Period of non-recurrence, 4) Reduction of UC-DAI score
Time frame: Week 48
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 4 Apr 2013.
- Derived from this study: PubMed 26905266Sun J, Yuan Y. Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Remission Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study. Adv Ther. 2016 Mar;33(3):410-22. doi: 10.1007/s12325-016-0304-y. Epub 2016 Feb 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Asacol® and Mesalazine in people with Ulcerative Colitis in Remission, run by Tillotts Pharma AG at 1 site in China.
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 1 inclusion and 1 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 4 Apr 2013. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of non-emergence of bloody stool (time frame: Week 48). 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 NCT01257399, 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 4 Apr 2013.