Colitis, UlcerativePhase 2NCT00545389
Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476
A Phase 2 study testing SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine in people with Colitis, Ulcerative, run by Shire at 1 site in Belgium.
Trial summary
Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine
- How many people
- 38 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Feb 2003to 20 Oct 2004
- Phase
- Phase 2
- 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
- male \& female subjects greater than or equal to 18 years of age with newly diagnosed or relapsing mild to moderate ulcerative colitis
- general medical assessment satisfactory and no clinically significant and relevant abnormalities
Who cannot join
- severe ulcerative colitis
- subject in relapse for > 6 weeks
- use of systemic or rectal steroids within last 4 weeks prior to baseline
- subjects with proctitis, previous colonic surgery, Crohn's disease, bleeding disorders, active ulcer disease
- subjects hypersensitive to salicylates/aspirin
- subjects with moderate or severe renal impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Randomized, Multi-centre, Double-blind, Parallel-group, Dose-ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once Daily
Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).
- Conditions
- Colitis, Ulcerative
- Being tested
- SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazineDrug
Also called LIALDA
What is being measured
The primary outcome is the main question the study is designed to answer.
% of subjects in remission (UC-DAI score)
Measured: Week 8
Secondary outcomes (3)
Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology
Measured: 8 weeks
Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA
Measured: 8 weeks
Safety and tolerability
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study start10 Feb 2003
- Primary completion20 Oct 2004
- Study completion20 Oct 2004
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 Colitis, UlcerativeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545389
- Sponsor's protocol ID
- SPD476-202
- Status last verified
- Jun 2021
- First submitted
- 16 Oct 2007
- Last updated
- 11 Jun 2021
- Results posted
- No
Publications
D'Haens G, Hommes D, Engels L, Baert F, van der Waaij L, Connor P, Ramage J, Dewit O, Palmen M, Stephenson D, Joseph R. Once daily MMX mesalazine for the treatment of mild-to-moderate ulcerative colitis: a phase II, dose-ranging study. Aliment Pharmacol Ther. 2006 Oct 1;24(7):1087-97. doi: 10.1111/j.1365-2036.2006.03082.x.
PubMed 16984503
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Multi-centre, Double-blind, Parallel-group, Dose-ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once Daily
- ClinicalTrials.gov ID
- NCT00545389
- Acronym / sponsor ID
- SPD476-202
- Conditions
- Colitis, Ulcerative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2003 (actual)
- Primary completion
- 20 Oct 2004 (actual)
- Study completion
- 20 Oct 2004 (actual)
- First posted
- 17 Oct 2007 (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.
Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male \& female subjects greater than or equal to 18 years of age with newly diagnosed or relapsing mild to moderate ulcerative colitis
- general medical assessment satisfactory and no clinically significant and relevant abnormalities
Key exclusion criteria (6 listed)
- severe ulcerative colitis
- subject in relapse for > 6 weeks
- use of systemic or rectal steroids within last 4 weeks prior to baseline
- subjects with proctitis, previous colonic surgery, Crohn's disease, bleeding disorders, active ulcer disease
- subjects hypersensitive to salicylates/aspirin
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 |
|---|---|---|
| SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazineAlso: LIALDA | Drug | – |
Primary outcome
% of subjects in remission (UC-DAI score)
Time frame: Week 8
3 secondary outcomes
Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology
Time frame: 8 weeks
Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA
Time frame: 8 weeks
Safety and tolerability
Time frame: 8 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 11 Jun 2021.
- Results publication: PubMed 16984503D'Haens G, Hommes D, Engels L, Baert F, van der Waaij L, Connor P, Ramage J, Dewit O, Palmen M, Stephenson D, Joseph R. Once daily MMX mesalazine for the treatment of mild-to-moderate ulcerative colitis: a phase II, dose-ranging study. Aliment Pharmacol Ther. 2006 Oct 1;24(7):1087-97. doi: 10.1111/j.1365-2036.2006.03082.x.
- FDA-approved label, US onlyLink provided by the sponsor.
- FDA Recall informationLink provided by the sponsor.
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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.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine in people with Colitis, Ulcerative, run by Shire at 1 site in Belgium.
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 2 inclusion and 6 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 11 Jun 2021. 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 Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
% of subjects in remission (UC-DAI score) (time frame: Week 8). 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 NCT00545389, 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 11 Jun 2021; AzTrials last refreshed its copy on 29 Oct 2026.