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Budesonide for Induction of Remission in Incomplete Microscopic Colitis

Sponsor
Dr. Falk Pharma GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT02142634
Collaborator
(none)
44
Enrollment
2
Locations
2
Arms
69.1
Duration (Months)
22
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.

Condition or Disease Intervention/Treatment Phase
  • Drug: Budesonide granules 9 mg
  • Drug: Placebo granules
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomised, Double-blind, Placebo-controlled, Multi-centre Trial on the Efficacy and Safety of Budesonide for Induction of Remission in Incomplete Microscopic Colitis
Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Feb 1, 2020
Actual Study Completion Date :
Feb 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Budesonide granules 9 mg

Drug: Budesonide granules 9 mg
per day
Placebo Comparator: B

Placebo granules

Drug: Placebo granules
per day

Outcome Measures

Primary Outcome Measures

  1. Rate of clinical remission [8 weeks]

Secondary Outcome Measures

  1. Rate of clinical remission [2 weeks]

  2. Rate of clinical remission [6 weeks]

  3. Time to remission [8 weeks]

  4. Number of formed/soft/watery stools per week [8 weeks]

  5. Number of days with abdominal pain [8 weeks]

  6. Number of days with urgency [8 weeks]

  7. Rate of histological remission [8 weeks]

  8. Physician's global assessment at final visit [8 weeks]

  9. Quality of life [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Histologically established diagnosis of incomplete microscopic colitis (MCi)

  • History of chronic non-bloody, watery diarrhoea

  • Clinically active disease

Exclusion Criteria:

  • Other significant abnormalities in colonoscopy

  • Infectious cause of diarrhoea

  • Clinical suspicion of drug-induced diarrhoea

  • Prior and present MC

  • History of bowel resection

  • Radiation therapy of the abdominal or pelvic region

  • Positive antibody titres for celiac disease

  • Untreated active thyroid dysfunction

  • Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy

  • Abnormal hepatic function

  • Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured

  • History of colorectal cancer

  • History of cancer (other than colorectal) in the last 5 years

  • Therapy with immunomodulators/budesonide or other steroids/antibiotics/anti-diarrhoeal drugs

  • Current or intended pregnancy or breast-feeding

  • Doubt about the patient's cooperation, e.g. because of addiction to alcohol or drugs

  • Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Digestive Diseases Hamburg Germany 20249
2 University Hospital of Linköping, Dept. of Gastroenterology and Hepatology Linköping Sweden 58185

Sponsors and Collaborators

  • Dr. Falk Pharma GmbH

Investigators

  • Principal Investigator: Andreas Münch, MD, University Hospital of Linköping, Dept. of Gastroenterology and Hepatology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT02142634
Other Study ID Numbers:
  • BUG-3/MIC
  • 2013-001912-31
First Posted:
May 20, 2014
Last Update Posted:
Jul 22, 2020
Last Verified:
Jul 1, 2020
Additional relevant MeSH terms:
Colitis
Colitis, Microscopic
Budesonide

Study Results

No Results Posted as of Jul 22, 2020