NCT01966783
Completed
Phase 2
Randomized, Double-blind, Multicentre Study to Compare the Efficacy and Safety of Budesonide Versus Mesalazine Suppository Versus a Combination Therapy of Budesonide/Mesalazine Suppositories in Patients With Acute Ulcerative Proctitis
ConditionsProctitis
Overview
- Phase
- Phase 2
- Intervention
- Budesonide 2 mg suppository
- Conditions
- Proctitis
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 320
- Locations
- 2
- Primary Endpoint
- Resolution of clinical symptoms
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.
Investigators
Eligibility Criteria
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
Arms & Interventions
Budesonide dosage 1
Budesonide 2 mg suppository
Intervention: Budesonide 2 mg suppository
Budesonide dosage 2
Budesonide 4 mg suppository
Intervention: Budesonide 4 mg suppository
Mesalazine
Mesalazine 1g suppository
Intervention: Mesalazine 1 g suppository
Combination
Budesonide 2 mg suppository/Mesalazine 1 g suppository
Intervention: Budesonide 2 mg suppository/Mesalazine 1 g suppository
Outcomes
Primary Outcomes
Resolution of clinical symptoms
Time Frame: 8 weeks
Symptoms as reported in the diary
Secondary Outcomes
- Rate of patients with clinical remission(8 weeks)
- Rate of clinical and endoscopic remission(8 weeks)
- Rate of improvement(8 weeks)
- Rate of patients with endoscopic remission(8 weeks)
Study Sites (2)
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