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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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13 December 2021 |
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Main ID: |
EUCTR2009-017044-13-FR |
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Date of registration:
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22/06/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate
the Effect of Remission Status on the Ability to Maintain or Achieve
Clinical and Endoscopic Remission During a 12-Month, Long-term
Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine
Once Daily in Adult Subjects With Ulcerative Colitis
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Scientific title:
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A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate
the Effect of Remission Status on the Ability to Maintain or Achieve
Clinical and Endoscopic Remission During a 12-Month, Long-term
Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine
Once Daily in Adult Subjects With Ulcerative Colitis |
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Date of first enrolment:
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27/07/2010 |
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Target sample size:
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1000 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017044-13 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Belgium
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Czech Republic
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France
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Germany
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Hungary
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Ireland
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Subjects meeting all of the criteria listed below at screening may be included in the study:
1. Adults aged 18 years or older.
2. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.
3. Diagnosis of active mild to moderate UC (acute flare or newly diagnosed with a total score of 4–10 inclusive on the modified UC-DAI with an endoscopy score of =1 and a PGA of =2)*. The original diagnosis of UC must be established by endoscopy, colonoscopy, or barium enema and have compatible histology.
4. Stable maintenance therapy of 5-ASA =3.2g/day (excluding MMX mesalamine/mesalazine), if 5-ASA is being taken at the onset of acute flare. Stable maintenance therapy is defined as no change in dose, or no initiation of 5-ASA, from the onset of the acute flare through baseline.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Subjects are excluded from the study if any of the following criteria are met at screening:
1. Severe UC (assessed by PGA =3).*
2. Acute flare with onset >6 weeks prior to baseline.
3. Acute flare while on maintenance MMX mesalamine/mesalazine (LIALDA®, MEZAVANT®, MEZAVANT® XL,MEZAVANT® LP).
4. Unsuccessfully treated current acute flare using steroids or 5-ASA doses >3.2g/day.
5. Acute flare on a 5-ASA maintenance therapy of >3.2g/day.
6. Systemic or rectal steroids use within the 4 weeks prior to screening or immunosuppressants within the last 6 weeks prior to screening.
7. History of biologic (anti-TNF agent) use.
8. Antibiotic use or repeated use (>3 consecutive days of use at doses above the prescribed over-the-counter dose) of any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen, within 7 days prior to screening. However, prophylactic use of a stable dose of aspirin up to 325mg/day for cardiac disease is permitted.
9. Current or recurrent disease, other than UC, that could affect the colon, the action, absorption, or disposition of the investigational medicinal product, or clinical or laboratory assessments.
* The symptom parameters of the modified UC-DAI (rectal bleeding and stool frequency) will be assessed at screening and baseline, and endoscopy and PGA scores will be obtained at baseline to confirm eligibility.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
MedDRA version: 12.1
Level: LLT
Classification code 10045365
Term: Ulcerative colitis
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Intervention(s)
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Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Current Sponsor code: SPD476
Other descriptive name: MMX Mesalamine/Mesalazine
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1.2-
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Primary Outcome(s)
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Main Objective: The primary objective of this study is to compare the percentage of subjects in complete (clinical and endoscopic) remission after 12 months of maintenance treatment with 2.4g/day MMX mesalamine/mesalazine given once daily (QD) between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment with 4.8g/day MMX mesalamine/mesalazine given QD.
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Secondary Objective: 1. To compare the percentage of subjects in clinical remission at 12 months between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.
2. To compare the time to relapse between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.
3. To compare the percentage of subjects who achieve or maintain mucosal healing (endoscopy score =1) at 12 months between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.
4. To assess the improvement in symptoms at 3 and 8 weeks of acute treatment.
5. To assess the percentage of subjects who achieve complete remission at the end of 8 weeks acute treatment.
6. To assess the safety and tolerability of MMX mesalamine/mesalazine.
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Primary end point(s): The primary efficacy endpoint is to compare the proportion of subjects in complete (clinical and endoscopic) remission after 12 months of maintenance treatment with 2.4g/day MMX mesalamine/mesalazine given QD between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment with 4.8g/day MMX mesalamine/mesalazine given QD.
Complete (clinical and endoscopic) remission is defined as a modified UC-DAI =1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in
endoscopy score from baseline (Visit 0).
Partial remission is defined as a modified UC-DAI =3 with a combined stool frequency and rectal bleeding score of =1 and not in complete remission.
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Secondary ID(s)
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2009-017044-13-GB
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SPD476-409
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 27/07/2010
Contact:
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