Budesonide 9 mg Capsules in Active UC

Open-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative Colitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02550418

Acronym

TOPICAL-1

Enrollment

Registered

2015-09-15

Start date

2015-10-31

Completion date

2017-03-31

Last updated

2017-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Ulcerative

Brief summary

The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis

Interventions

DRUGBudesonide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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, * Established disease,

Exclusion criteria

* Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis, * Toxic megacolon or fulminant colitis, * Colon resection, * Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening), * Malabsorption syndromes, * Celiac disease, * Bleeding hemorrhoids, * Active peptic ulcer disease * Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding, * Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured, * Any severe infectious disease (e.g., tuberculosis, AIDS), * Severe co-morbidity substantially reducing life expectancy, * History of colorectal cancer, * History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma

Design outcomes

Primary

Measure	Time frame	Description
Rate of clinical remission at final/withdrawal visit	8 weeks treatment	Clinical remission includes normalisation of stool frequency and absence of blood in stools

Secondary

Measure	Time frame
Rate of endoscopic remission/improvement at final/withdrawal visit	8 weeks treatment
Number of stools / bloody stools per week	8 weeks treatment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026