Budesonide for induction of remission in incomplete microscopic colitis

Phase 1

• Conditions: Patients with active incomplete microscopic colitis; MedDRA version: 20.0 Level: PT Classification code 10056979 Term: Colitis microscopic System Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-001912-31-AT
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-28
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 106

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
4. History of chronic non-bloody, watery diarrhoea for at least 4 weeks
5. Clinically active disease

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

1. Other significant abnormalities in colonoscopy that may have been the cause of diarrhoea
2. Infectious cause of diarrhoea
3. Clinical suspicion of drug-induced diarrhoea
4. Prior and present MC
5. History of bowel resection (except appendectomy, haemorrhoidectomy and endoscopic removal of polyps)
6. Radiation therapy of the abdominal or pelvic region
7. Positive antibody titres for celiac disease or any kown history of celiac disease
8. History of colorectal cancer
9. Therapy with immunomodulators within the last 3 months
10. Treatment with budesonide, other steroids or antibiotics within the last 4 weeks
11. Treatment with anti-diarrhoeal drugs, bulking agents, and spasmolytics within the last 2 weeks
12. History of colorectal cancer
13. History of cancer (other than colorectal) in the last 5 years
14. therapy with immunomodulators within 3 months prior to baseline 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, cholestyramine, bulking agents, spasmolytics, bismuth and probiotics within 2 weeks prior to baseline
18. Known intolerance/hypersensitivity/resistance to the trial drug
19. Current or intended pregnancy or breast-feeding
20. Doub about the patient's cooperation
21. Participation in another clinical trial within the last 30 days, simultaneous participation in another trial or previous participation in this trial
22. Liver vaccination within the last 4 weeks before the baseline visit
23. Diagnosis of chickenpox, herpes zoster or measles within the last 3 months before the baseline visit
14.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified