Proctitis
Conditions
Brief summary
The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.
Interventions
DRUGBudesonide 4 mg suppository
per day
DRUGMesalazine 1 g suppository
per day
DRUGBudesonide 2 mg suppository/Mesalazine 1 g suppository
per day
DRUGBudesonide 2 mg suppository
per day
Sponsors
Dr. Falk Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Active ulcerative proctitis * Diagnosis confirmed by endoscopy * Established disease or new diagnosis
Exclusion criteria
* Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular assoc. colitis, microscopic colitis * Presence of proctitis of a different origin * Prior bowel resection * Presence of symptomatic organic disease of the gastrointestinal tract * Asthma, tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection if careful medical monitoring is not ensured * Local intestinal infection * Abnormal hepatic or renal function * Oral/rectal/intravenous corticosteroids therapy * Existing or intended pregnancy or breast-feeding * Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of clinical symptoms | 8 weeks | Symptoms as reported in the diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of clinical and endoscopic remission | 8 weeks | Symptoms as reported in the diary, ulcerative colitis-disease activity index |
| Rate of improvement | 8 weeks | Symptoms as reported in the diary, ulcerative colitis-disease activity index |
| Rate of patients with clinical remission | 8 weeks | Symptoms as reported in the diary, ulcerative colitis-disease activity index |
| Rate of patients with endoscopic remission | 8 weeks | Ulcerative colitis-disease activity index |
Countries
Germany
Outcome results
None listed