Budesonide 9 mg Capsules in Active UC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Colitis, Ulcerative

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Budesonide

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

Interventions

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Budesonide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No