TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)

Dr. Falk Pharma

Status and phase: Completed; Phase 3

Conditions: Active Ulcerative Colitis

Treatments: Drug: Mesalazine - TID 1000 mg; Drug: Mesalazine - TID 2x 500 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01745770

SAT-25/UCA

Details and patient eligibility

About

The purpose of the trial is to proof whether TID 1000 mg mesalazine is non-inferior to TID 2x 500 mg mesalazine in the treatment of patients with acute ulcerative colitis

Enrollment: 306 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Men or women aged 18 to 75 years
• Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology

Exclusion criteria

• Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis)
• Toxic megacolon
• Screening stool positive for germs causing bowel disease
• Malabsorption syndromes
• Celiac disease
• Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhoea or gastrointestinal bleeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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306 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Mesalazine - TID 1000 mg

B

Active Comparator group

Treatment:

Drug: Mesalazine - TID 2x 500 mg