Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.
Multicentre, Controlled, Randomised, Investigator-Blinded, Comparative Study of Oral Mesalazine 4g Once Daily Versus Mesalazine 4g in Two Divided Doses in Patients With Active Ulcerative Colitis.
2 other identifiers
interventional
206
4 countries
66
Brief Summary
The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily (QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks, in terms of remission evaluated with the Ulcerative Colitis Disease Activity Index (UC-DAI) score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) received an enema containing 1g of mesalazine at bedtime during the initial 4 weeks. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2008
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2008
CompletedFirst Posted
Study publicly available on registry
August 20, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedMarch 4, 2015
March 1, 2015
1.6 years
August 19, 2008
March 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Primary efficacy criterion: remission after 8 weeks of treatment, defined on the basis of the UC-DAI score less than or equal to 1
12 weeks
Secondary Outcomes (9)
Compliance
Week 8
Clinical remission
At week 4, week 8 and week 12
Treatment failure is defined as need of other treatment (ie steroids, immunosuppressive or immunomodulating drugs) than those allowed by the protocol, as judged by investigator. Treatment failure will be counted as non-remission.
At week 4 and week 8
Clinical variables (stool frequency and bloody stools)
At week 4, 8 and 12 separately
Time to remission according to patient's diary (normal stool frequency and cessation of bleeding)
At week 4 and week 8
- +4 more secondary outcomes
Study Arms (2)
Mesalazine once/day
EXPERIMENTALParticipants 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 twice/day
ACTIVE COMPARATORParticipants 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).
Interventions
Mesalazine 2g Sachet prolonged release granules, administered orally.
1g mesalazine liquid enema, administered topically once a day in the evening.
Eligibility Criteria
You may qualify if:
- Aged 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).
- 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.
You may not qualify if:
- Proctitis (less than 12-18 cm from the anorectal junction).
- 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).
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
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
Related Publications (1)
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.
PMID: 23451806DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2008
First Posted
August 20, 2008
Study Start
November 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
March 4, 2015
Record last verified: 2015-03