Status:
COMPLETED
Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 da...
Detailed Description
A key element in therapeutic response in UC is treatment compliance. In daily practice, compliance of UC patients with 5-Amino Salicylic Acid (5-ASA) treatment appears mediocre, particularly in mainte...
Eligibility Criteria
Inclusion
- Patients will be included if they comply with the following inclusion criteria determined at baseline, prior to first drug administration:
- 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).
- 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
- The patients will not be included in the study if one of the following exclusion criteria is fulfilled at baseline, prior to first drug administration:
- 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).
- Known significant hepatic or renal function abnormalities.
- Moderate/severe abnormal renal, hepatic or blood count tests defined as: creatinine plasma value \> 1.5 x Upper Limit of Normal (ULN) or white blood cells \< 3500/mm˄3 or \> 15000/mm˄3 or Platelets \< 100000/mm˄3 or \> 800000/mm˄3 or aspartate aminotransferase/alanine Aminotransferase (ASAT/ALAT) \> 3 x ULN or Gamma glutamyl transpeptidase (GGT)/Alkaline Phosphatase's \> 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT00737789
Start Date
November 1 2008
End Date
June 1 2010
Last Update
March 4 2015
Active Locations (66)
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1
O.L.Vrouwziekenhuis Campus Aalst
Aalst, Belgium
2
C.H.U. Saint-Pierre
Brussels, Belgium
3
Saint Luc University Hospital
Brussels, Belgium
4
Universitair Ziekenhuis Brussel
Brussels, Belgium