Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulce… (NCT01966783) | Clinical Trial Compass
CompletedPhase 2
Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis
Germany320 participantsStarted 2013-09
Plain-language summary
The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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