ovel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis

Phase 1

• Conditions: acute ulcerative colitis; MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-003334-16-LV
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-14
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Signed informed consent,

Man or woman between 18 and 75 years of age,

Acute ulcerative colitis,

New diagnosis or established disease,

diagnosis confirmed by total colonoscopy and biopsy

Mildly to moderately active ulcerative colitis (3 < modified UC-DAI < 11), with rectal bleeding subscore of = 1, and endoscopic subscore of = 2 at the most active site in the segment of the rectum
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 282
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 78

Exclusion Criteria

Crohn’s disease, indeterminate colitis, ischemic colitis, diverticular disease-associated colitis, microscopic colitis

Presence of colitis of a different origin (e.g. infectious or parasitic, drug-induced),

Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps),

Abnormal laboratory values, presence of or suspected concomitant disease(s) that could affect study-specific assessments and/or their evaluation, or might compromise patients' safety and/or compliance (e.g. organic diseases or infections of the gastrointestinal tract (with exceptions), certain malignancies or cancers, certain metabolic disorders)

Regular oral treatment with more than 2.4 g/d mesalazine (or therapeutic equivalent, i.e., either > 2.4 g/d olsalazine, > 5.6 g/d balsalazide, or > 6.2 g/d sulfasalazine) within the last 4 weeks prior to baseline,

Regular rectal treatment with more than 0.5 g/d mesalazine, olsalazine or more than 1 g/d sulfasalazine within the last 4 weeks prior to baseline,

Oral/rectal/intravenous corticosteroids therapy within the last 4 weeks priorto screening endoscopy,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified