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: 16.1 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-HU
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-22
• 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
6. Radiation therapy of the abdominal or pelvic region
7. Positive antibody titres for 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

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>