NL-OMON45182
Completed
Phase 3
Randomised, double-blind, placebo-controlled, multi-centre trial on the efficacy and safety of budesonide for induction of remission in incomplete microscopic colitis - BUG-3/MIC
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Incomplete microscopic colitis
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 1
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed informed consent,
- •2\. Man or woman between 18 and 80 years of age,
- •3\. Histologically established diagnosis of incomplete microscopic colitis (MCi) defined as the following findings in at least two segments of the colon:
- •\* increased lymphoplasmacellular infiltrate in the lamina propria and
- •\* thickened subepithelial collagenous band \> 5 \*m and \< 10 \*m and/or
- •\* abnormal intraepithelial lymphocytes \> 5 and \< 20 per 100 epithelial cells,
- •4\. History of chronic non\-bloody, watery diarrhoea for at least 4 weeks,
- •5\. Clinically active disease (defined as a mean of \* 3 stools/day, thereof a mean of \* 1 watery stool/day during the week prior to randomisation),
- •6\. Women of child\-bearing potential have to apply during the entire duration of the study a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, some IUDs, sexual abstinence or vasectomised
- •partner. The investigator is responsible for determining whether the patient uses adequate birth control for study participation.
Exclusion Criteria
- •1\. Other significant abnormalities in colonoscopy that may have been the cause of diarrhoea except for colonic diverticulosis and non\-dysplastic polyps \< 2 cm,
- •2\. Infectious cause of diarrhoea (local routine stool samples, Clostridium difficile included) or history of infectious diarrhoea within the last 3 months prior inclusion or local intestinal infection,
- •3\. Clinical suspicion of drug\-induced diarrhoea,
- •4\. Prior and present MC (i.e., all histological criteria for collagenous colitis or lymphocytic colitis fulfilled),
- •5\. History of bowel resection,
- •6\. Radiation therapy of the abdominal or pelvic region,
- •7\. Positive antibody titres for celiac disease (tGT IgA \+ serum IgA),
- •8\. Untreated active thyroid dysfunction,
- •9\. Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy,
- •10\. Abnormal hepatic function (ALT or ALP \> 2\.5 x upper limit of normal \[ULN]), liver cirrhosis, or portal hypertension,
Outcomes
Primary Outcomes
Not specified
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