acute ulcerative proctitis
Conditions
Interventions
Product Code: Salofalk 1000 mg Suppository
Pharmaceutical Form: Suppository
INN or Proposed INN: Mesalazine
CAS Number: 89-57-6
Other descriptive name: 5-Aminosalicylic acid
Concentration unit: mg mil
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - signed informed consent - Man or woman between 18 and 75 years of age - Active ulcerative proctitis, i.e. inflammation/lesions maximal 15 cm of rectum - Diagnosis confirmed by endoscopy and histological examination - Established disease or new diagnosis - Mildly to moderately active ulcerative proctitis (3 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Crohn’s disease - proctitis of a different origin - Prior bowel resection leading to diarrhoea and/or pouch formation - Toxic megacolon - Hemorrhagic diathesis - symptomatic organic disease of the gastrointestinal tract - Active colorectal cancer or a history of colorectal cancer - Active malignancy other than colorectal cancer or treatment with anticancer drugs during the last 5 years - asthma, active peptic ulcer disease, infection - Abnormal hepatic function or liver cirrhosis - Abnormal renal function - Regular oral treatment with more than 2 g/day 5-ASA, olsalazine or more than 5 g/day sulfasalazine within the last four weeks - Regular rectal treatment with more than 0.5 g/day 5-ASA, olsalazine or more than 1 g/day sulfasalazine within the last four weeks - Corticosteroid therapy within the previous one month - Immunosuppressive drugs or anti-TNF-a therapy within the previous three months - Application of non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before baseline visit - Known intolerance/hypersensitivity/resistance to study drugs or drugs of similar chemical structure or pharmacological profile -Intake of Cycloferon within the last four weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To proof the therapeutic equivalence of once daily (OD) 1.0 g mesalazine suppositories versus three times daily (TID) 0.5 g mesalazine suppositories in patients with active ulcerative proctitis;Secondary Objective: To study safety and tolerability in the form of adverse events and laboratory parameters To assess patients' acceptance of the study drug To assess patients' preference regarding administration schedule To assess patients' quality of life;Primary end point(s): Rate of remission (defined by DAI < 4) at the final / withdrawal visit | — |
Countries
Germany
Outcome results
None listed