Budesonide 9 mg Capsules in Active UC (TOPICAL-1)

Dr. Falk Pharma

Status and phase

Completed

Phase 2

Conditions

Colitis, Ulcerative

Treatments

Drug: Budesonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02550418

BUX-3/UCA

Details and patient eligibility

About

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

Enrollment

60 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,
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