Randomized, single-blind, multicentre study to compare the efficacy and safety of once daily 1 g mesalazine suppositories versus three times daily 0.5 g mesalazine suppositories in patients with acute ulcerative proctitis - OD vs. TID dosing with mesalazine suppositories in acute ulcerative proctitis
- Conditions
- acute ulcerative proctitis
- Registration Number
- EUCTR2004-005018-35-DE
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 380
- 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 < DAI < 11)
- Women of child-bearing potential have to apply appropriate contraceptive methods
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method