Ulcerative collitis (UC) MedDRA version: 4.1 Level: PT Classification code 10009900
Conditions
Interventions
Trade Name: Pentasa sachet 1g
Product Name: Pentasa
Pharmaceutical Form: Prolonged-release granules
INN or Proposed INN: mesalazine
Other descriptive name: 5-AminoSalicylic Acid
Trade Name: NA
Produ
Sponsors
Ferring BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA: 1. Patients have an established diagnosis of ulcerative colitis and are in clinical remission with an UC-DAI 15 cm distance from anal verge, 3. Patients who have had a clinical relapse within the past year. Clinical relapse is defined as activity of the disease for which maintenance therapy had to be adjusted, 4. Patients on oral mesalazine maintenance therapy = 2.5 gram (sulfasalazine = 3.0 grams, olsalazine = 1.5 grams) per day. Patients without any oral mesalazine/ sulfasalazine/ olsalazine therapy at the time point of randomisation may be included provided they have, at some time point, had oral mesalazine/ sulfasalazine/ olsalazine therapy within the last 12 months, 5. 18 years or older, 6. Signed informed consent. 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
Exclusion criteria: EXCLUSION CRITERIA: 1. Patients with evidence of other forms of inflammatory bowel disease, idiopathic proctitis or infectious disease, 2. Patients allergic to acetylsalicylic acid and other salicylate derivates, 3. Patients who used mesalazine > 2.5 grams (sulfasalazine > 3.0 grams, olsalazine > 1.5 grams) orally per day in the previous month, 4. Patients who used rectal mesalazine > 3 grams (sulfasalazine > 3 grams) per week in the previous month, 5. Use of corticosteroids (oral and/or rectal routes) within the last month, 6. Intake of immunosuppressants within the last 3 months, 7. Patients with (known) significant hepatic or (known) renal function abnormalities; liver enzymes values exceeding 2 x upper limit of normal or serum creatinine values exceeding 1.5 x upper limit of normal value, 8. Patients with history or physical examination findings indicative of active alcohol or drug abuse, 9. Patients with a history of disease, including mental/emotional disorder, that would interfere with their participation in the study, 10. Women who are pregnant or nursing (non-menopausal women who are sexually active and use not effective contraceptives as judged by the investigator must have a negative pregnancy test), 11. Patients who participated in another clinical study in the last 3 months, 12. Patients who were previously participating in this study, 13. Patients with any other disease that may influence the study assessment, such as malignant disease etc, 14. Patients who are unable to comply with any requirements of the protocol, 15. Patients who are unable to write or read local language.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish that remission in UC with a once daily oral treatment with 2 gram Pentasa® prolonged release granules per day is non-inferior to a twice daily oral scheme with 1 gram Pentasa® prolonged release granules. Primary Objective To demonstrate that 2 gram mesalazine once daily is non-inferior to 1 gram mesalazine twice daily in terms of remission rate in patients with mild to moderate ulcerative colitis. ;Secondary Objective: To compare between the two groups • Compliance • Time to relapse • Severity of relapse • Endoscopic evaluation • Average of UC-DAI* at each visit • Acceptability • Incidence of Adverse Events * abbreviated at visit 2 and 3 ;Primary end point(s): Primary Objective To establish that remission in UC with 2 gram Pentasa® sachets per day is non-inferior to a twice daily oral scheme with 1 gram Pentasa® sachets. | — |
Countries
Czech Republic, Denmark, Finland, Germany, Norway, Sweden
Outcome results
None listed