Randomised, double-blind, placebo-controlled, multi-centre trial on the efficacy and safety of budesonide for induction of remission in incomplete microscopic colitis

Phase 1

• Conditions: Patients with active incomplete microscopic colitis; MedDRA version: 20.1 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-DK
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-03
• Last Update Posted: 11 March 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 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 (except appendectomy, haemorrhoidectomy and endoscopic removal of polyps),
6. Radiation therapy of the abdominal or pelvic region,
7. Positive antibody titres for celiac disease (tGT IgA + serum IgA), or any known history of celiac disease,
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, spasmolytics, bismuth, and probiotics 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,
22. Live 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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to demonstrate efficacy of budesonide for induction of remission in patients with active incomplete microscopic colitis;Secondary Objective: The second objective of the trial is to study the maintenance of remission after end of treatment and the safety, tolerability of budesonide granules in patients with incomplete microscopic colitis;Primary end point(s): Rate of clinical remission at final/withdrawal visit;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Each visit, if not otherwise defined;<br> Secondary end point(s): Double-blind phase:<br> • Rate of clinical remission <br> • Time to remission<br> • Change in total number of stools<br> • Change in number of days with abdominal pain <br> • Change in number of days with bloating <br> • Changes in histological signs <br> • Rate of histological remission/improvement <br> • Physician’s Global Assessment (PGA) <br> • Short Health Scale (SHS)<br> <br> Follow-up phase:<br> • Rate of responders maintaining clinical remission<br> • Rate of patients with relapse<br> • Time to relapse<br>