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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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4 January 2022 |
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Main ID: |
EUCTR2008-000045-59-BE |
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Date of registration:
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22/09/2008 |
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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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Multicentre, controlled, randomized, investigator-blinded, comparitive study of oral Mesalazine 4 g per day Once daily versus 4 g per day in Two divided doses in patients with Active Ulcerative Colitis. - MOTUS
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Scientific title:
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Multicentre, controlled, randomized, investigator-blinded, comparitive study of oral Mesalazine 4 g per day Once daily versus 4 g per day in Two divided doses in patients with Active Ulcerative Colitis. - MOTUS |
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Date of first enrolment:
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23/12/2008 |
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Target sample size:
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398 |
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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:2008-000045-59 |
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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: yes
Randomised: yes
Open: no
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: investigator blinded, patient opened
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: same IMP, the comparator is the reference regiment 4 gper day in 2 idvided doses (BID)
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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France
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Netherlands
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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:
- Age over 18 years
- Newly diagnosed or relapsing mild to moderate ulcerative colitis with disease extension beyond rectum (of at least 12-18 cm from the anorectal junction). All patients must have had at least one total colonoscopy in their disease history (within the previous 5 years).
- Disease activity will be assessed on the 7 days before inclusion and according to ulcerative colitis disease activity index (UC-DAI) score. The UC-DAI score will be from 3 to 8 (mild: 3-5 or moderate: 6-8).
- Men or non-pregnant women.
- Women with childbearing potential must be using a contraceptive method judged effective by the investigator.
- Oral maintenance treatment with azathioprine or 6-mecraptopurine (taken for at least 6 months and continued at the same dose throughout the study) is permitted.
- informed consent given.
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:
- proctitits (less than 12-18 cm from the anorectal junction
- previous colonic surgery.
- previous failed to respond to steroids within the previous year.
- Non-response to rectal 5-ASA therapy or to oral 5-ASA therapy at dose > 3/day for induction of remission within the previous year.
- Current relapse lasting more than 6 weeks (from what patient says).
- Severe/fulminant ulcerative colitis
- Evidence of other forms of inflammatory bowel disease or infectious disease.
- Allergy to aspirin or salicylate derivatives.
- The following treatment will be forbidden during the study (if present at selection, a wash-out will be necessary):
* Loperamide and other antidiarrheal agents, mucilages, antibiotics
(metronidazole) and ciproflocacin): 1 week wash-out.
* Oral steroids: 4 weeks wash-out.
* Rectal steroids: 2 weeks wash-out
* Repeated treatment (> 3 days of use) of non-steroidal anti-inflammatory drugs
(NSAID) oral or rectal route: 1 week wash-out (aspirin for cardioprotection is allowed.
* Sulfasalzine > 4g or mesalazine or 4-ASA at a higher dose than what it is
permitted in the local formulary or standard care for maintenance treatment: 4
weeks wash-out.
* Immunomodulating/suppressing drugs: 3 month for wash-out (except for
patients maintained on azathioprine or 6-mercaptopuring-see above)
- Known significant hepatic or renal function abnormalities.
- Moderate/severe abnormal renal, hepatic or blood count tests defineda as: creatinine plasma value > 1.5 x ULN or white blood cells <3500/mm3 or > 15000/mm3 or platelets <100000/mm3 or > 800000/mm3 or ASAT/ALAT >3 x ULN or GGT/Alkalin Phosphatases > 3 x ULN (Primary Sclerosing Cholangitis is not an exclusion criteria).
- History or physical examination findings indicative of active alcohol or drug abuse.
- Pregnancy or breast-feeding
- History of disease, including mental/emotional disorder, that might interfere with their participation in the study.
- Participation in another clinical study in the last 3 months.
- Inability to comply with the protocol requirements.
- Inability to fill in the diary cards
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Patients with mild to moderate ulcerative colitis
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Intervention(s)
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Product Name: Pentasa 2g sachet prolonged release granules (95%)
Pharmaceutical Form: Granules
INN or Proposed INN: MESALAZINE
CAS Number: 89576
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 2-
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Primary Outcome(s)
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Secondary Objective: * Compliance
* Clinical remission at week 4 and week 8
* Clinical variables improvement (stools frequency and blood stools) at week 4, 8 and 12 seperately
* Treatment failure rates at W4 and W8
* Time to remission according patient's diary (normal stools frequency and cessation of bleeding)
* Time to cessation of bleeding
* Improvement at week 4 and 8 based on UC-DAI score
* Endoscopic assessment at W0 and W8
* Acceptability of the treatment
* Safety
* Proportion of patients stayin in clinical remission at week 12.
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Main Objective: To demonstrate that mesalazine po 4 g per day once daily (QD.) is non-inferior to the reference regimen, mesalazine 4 g per day in two divided doses (BID.) (2g x 2 per day), in patients with active ulcerative colitis treated for 8 weeks, in terms of remission evaluated with the UC-DAI score and defined as 1. Both groups (4g QD and 2gx2) will receive an enema containing 1 g of mesalazine at bedtime during the initial 4 weeks.
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Primary end point(s): - Primary efficacy criterion: remission after 8 weeks of treatment, defined on the basis of the UC-DAI score - Seocndary efficacy variables
°Compliance at W8
°Clinical remission at W4, W8 and W12
°Treatment failure rates at W4 and W8 defined as the need for other treatment than those allowed by the protocol. Treatment failure will be counted as non-remission
°Clincal variables (stool frequency and bloody stools) at week 4, 8 and 12 seperately
° Time of cessation of bleeding
° Time to Remission according patient's diary (normal stools frequency and cessation of bleeding
°Improvement at week 4 and week 8 based on UC-DAI score
° Endoscopic assessment at week 0 and at week 8
° Acceptability of the treatment at week 4 and week 8
° Safety
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Secondary ID(s)
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Pentasa FE999907 CS06
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2008-000045-59-FR
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 23/12/2008
Contact:
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