Multicentre study on the efficacy and safety of budesonide in patients withincomplete microscopic colitis
- Conditions
- Induction of remission in incomplete microscopic colitisMedDRA version: 20.1Level: PTClassification code 10056979Term: Colitis microscopicSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2013-001912-31-IT
- Lead Sponsor
- DR. FALK PHARMA GMBH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 106
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 µm and < 10 µm 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
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 86
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
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,
11. Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer
disease, glaucoma, cataract, or infection if careful medical monitoring is
not ensured,
12. History of colorectal cancer,
13. History of cancer (other than colorectal) in the last 5 years,
14. Therapy with immunomodulators (e.g., azathioprine, 6-mercaptopurine, or
methotrexate) within 3 months prior to baseline,
15. Treatment with budesonide or other steroids within 4 weeks prior to
baseline,
16. Treatment with antibiotics within 4 weeks prior to baseline,
17. Treatment with anti-diarrhoeal drugs (e.g., loperamide, ispaghula, codeine,
and opium), cholestyramine, bulking agents, and spasmolytics within 2
weeks prior to baseline,
18. Known intolerance/hypersensitivity/resistance to the trial drug or drugs of
similar chemical structure or pharmacological profile,
19. Current or intended pregnancy or breast-feeding,
20. Doubt about the patient’s cooperation, e.g. because of addiction to alcohol
or drugs,
21. Participation in another clinical trial within the last 30 days, simultaneous
participation in another clinical trial, or previous participation in this trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method