Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis

Dr. Falk Pharma

Status and phase: Completed; Phase 2

Conditions: Proctitis

Treatments: Drug: Budesonide 2 mg suppository; Drug: Budesonide 2 mg suppository/Mesalazine 1 g suppository; Drug: Budesonide 4 mg suppository; Drug: Mesalazine 1 g suppository

Study type: Interventional

Funder types: Industry

Identifiers

NCT01966783

2012-003362-41 (EudraCT Number)

BUS-2/UCA

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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320 participants in 4 patient groups

Budesonide dosage 1

Experimental group

Description:

Budesonide 2 mg suppository

Treatment:

Drug: Budesonide 2 mg suppository

Budesonide dosage 2

Experimental group

Description:

Budesonide 4 mg suppository

Treatment:

Drug: Budesonide 4 mg suppository

Mesalazine

Active Comparator group

Description:

Mesalazine 1g suppository

Treatment:

Drug: Mesalazine 1 g suppository

Combination

Experimental group

Description:

Budesonide 2 mg suppository/Mesalazine 1 g suppository

Treatment:

Drug: Budesonide 2 mg suppository/Mesalazine 1 g suppository