Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.
NCT ID: NCT00737789
Last Updated: 2015-03-04
Study Results
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Basic Information
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COMPLETED
PHASE3
206 participants
INTERVENTIONAL
2008-11-30
2010-06-30
Brief Summary
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Participants in remission at week 8 received an additional 4 weeks of maintenance therapy with 2g oral mesalazine once a day. Participants who did not achieve remission at Week 8 completed the study at week 8.
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Detailed Description
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An inverse relationship has been found between the number of daily doses prescribed and treatment compliance. Thus, reduction to a single daily dose of mesalazine is a major factor likely to significantly increase treatment compliance.
Reducing the dosing rate to a single daily dose for 8 weeks constitutes a simple method of improving treatment compliance but it is necessary to demonstrate at least equivalent efficacy compared to the twice daily dosing which is the reference regimen. This study was designed to show that mesalazine 4g once daily is at least as effective as mesalazine 4g in two divided doses per day in patients with mild to moderate ulcerative colitis after 8 weeks of treatment with a better compliance. To improve remission, both groups received an enema during the first 4 weeks, as usually done in current practice.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mesalazine once/day
Participants received 4g oral Mesalazine once a day (2 sachets of prolonged release granules) for 8 weeks during the induction period. In addition, participants received a liquid enema of 1g Mesalazine once a day at bedtime for the first 4 weeks. Participants who were in remission at Week 8 received oral mesalazine 2g once daily (1 sachet/day) for an additional 4 weeks (maintenance period).
Mesalazine slow-release granules
Mesalazine 2g Sachet prolonged release granules, administered orally.
Mesalazine liquid enema
1g mesalazine liquid enema, administered topically once a day in the evening.
Mesalazine twice/day
Participants received oral mesalazine 4 g per day in two divided doses (1 sachet prolonged release granules twice a day) for 8 weeks during the induction period. In addition, participants received a liquid enema of 1g Mesalazine once a day at bedtime for the first 4 weeks. Participants who were in remission at Week 8 received oral Mesalazine 2g (one sachet) once a day for an additional 4 weeks (maintenance period).
Mesalazine slow-release granules
Mesalazine 2g Sachet prolonged release granules, administered orally.
Mesalazine liquid enema
1g mesalazine liquid enema, administered topically once a day in the evening.
Interventions
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Mesalazine slow-release granules
Mesalazine 2g Sachet prolonged release granules, administered orally.
Mesalazine liquid enema
1g mesalazine liquid enema, administered topically once a day in the evening.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 15 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-mercaptopurine (taken for at least 6 months at stable dose and continued at the same dose throughout the study) is permitted.
* Informed consent given.
Exclusion Criteria
* Previous colonic surgery.
* Previously failed to respond to steroids within the previous year.
* Non-response to rectal 5-Amino Salicylic Acid (5-ASA) therapy or to oral 5-ASA therapy at a dose \> 3g/day for induction of remission within the previous year.
* Current relapse lasting more than 6 weeks (for patient recently diagnosed the period of 6 weeks runs from the endoscopic diagnosis)(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: 1 week wash-out.
* Oral steroids: 4 weeks wash-out.
* Rectal steroids: 2 weeks wash-out
* Repeated treatment (\> 3days of use) of non steroidal anti-inflammatory drugs (NSAID) oral or rectal route: 1 week wash-out (aspirin ≤ 325 mg/day used for cardioprotection is allowed).
* Sulfasalazine \> 4g/day or mesalazine or 4-ASA at a higher dose than what 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-mercaptopurine -see above).
* Known significant hepatic or renal function abnormalities.
* 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.
18 Years
ALL
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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O.L.Vrouwziekenhuis Campus Aalst
Aalst, , Belgium
C.H.U. Saint-Pierre
Brussels, , Belgium
Saint Luc University Hospital
Brussels, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
U.Z. Antwerpen
Edegem, , Belgium
University Hospital Gasthuisberg
Leuven, , Belgium
Clinique Esquirol-St Hilaire
Agen, , France
Investigational site
Albi, , France
Investigational site
Amiens, , France
Centre Hospitalier Avignon
Avignon, , France
Centre Hospitalier Bethune
Béthune, , France
Investigational site
Bourgoin, , France
Investigational site
Brest, , France
Clinique Jean-Villar
Bruges, , France
Clinique Saint Martin - 18 rue Rocquemonts
Caen, , France
Clinique Saint Martin
Caen, , France
Investigational site
Caluire-et-Cuire, , France
Investigational site
Carcassonne, , France
Clinique du Parc
Castelnau-le-Lez, , France
Investigational site
Chambray-lès-Tours, , France
Centre Médical République
Clermont-Ferrand, , France
Investigational site
Clichy, , France
Clinique des Cèdres
Cornebarrieu, , France
Centre Hospitalier Intercommunal
Créteil, , France
Investigational site
Dunkirk, , France
Centre Hospitalier Universitaire Albert MICHALON
Grenoble, , France
Investigational site
Grenoble, , France
Investigational site
Hazebroucq, , France
Investigational site
Irigny, , France
Investigational site
Istres, , France
Centre Hospitalier Lagny
Lagny, , France
Investigational site
Le Mans, , France
Investigational site - 23 bis, place Sébastol
Lille, , France
Investigational site - 60 rue Jean Bart
Lille, , France
Clinique de la Sauvegarde
Lyon, , France
Investigational site - 186 avenue de la Rose
Marseille, , France
Investigational site - 23 Cours Gouffé
Marseille, , France
Investigational site
Miramas, , France
CH Le raincy-Montfermeil
Montfermeil, , France
Investigational site
Nancy, , France
Hôpital L'Archet 2
Nice, , France
Investigational site - 127 boulevard St Germain
Paris, , France
Investigational site - 72 rue Archeveau
Paris, , France
Investigational site - 91 rue Caulaincourt
Paris, , France
Investigational site
Perpignan, , France
Clinique Saint Martin
Pessac, , France
Hôpital de Lyon Sud
Pierre-Bénite, , France
Investigational site
Reims, , France
Centre Hospitalier Privé
Saint-Grégoire, , France
Investigational site - 140 avenue Lwoff
Saint-Priest, , France
Investigational site
Saint-Quentin, , France
Investigational site
Strasbourg, , France
Clinique Saint Jean Languedoc - 20 route de Revel
Toulouse, , France
Clinique Saint Jean-Languedoc
Toulouse, , France
Centre FUTURA MEDICA
Verquigneul, , France
Groupe Hospitalier les Portes du Sud
Vénissieux, , France
Kennemer Gasthuis, loc. EG
Haarlem, , Netherlands
Streekziekenhuis Midden Twente
Hengelo, , Netherlands
IJsselmeer Ziekenhuis Loc. Lelystad, Poli MDL
Lelystad, , Netherlands
Mumc / Azm
Maastricht, , Netherlands
Haga Ziekenhuis, loc.Rode Kruis
The Hague, , Netherlands
TweeSteden Ziekenhuis
Tilburg, , Netherlands
Isala Klinieken, loc. Sophia
Zwolle, , Netherlands
Bristol Royal Infirmary
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Royal Victoria Infirmary
Newcastle, , United Kingdom
Countries
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References
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Flourie B, Hagege H, Tucat G, Maetz D, Hebuterne X, Kuyvenhoven JP, Tan TG, Pierik MJ, Masclee AA, Dewit O, Probert CS, Aoucheta D; MOTUS study investigators. Randomised clinical trial: once- vs. twice-daily prolonged-release mesalazine for active ulcerative colitis. Aliment Pharmacol Ther. 2013 Apr;37(8):767-75. doi: 10.1111/apt.12266. Epub 2013 Mar 4.
Other Identifiers
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EudractCT No 2008-000045-59
Identifier Type: -
Identifier Source: secondary_id
Pentasa FE999907 CS06
Identifier Type: -
Identifier Source: org_study_id
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