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Budesonide for Induction of Remission in Incomplete Microscopic Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02142634
Recruitment Status : Active, not recruiting
First Posted : May 20, 2014
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

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
Incomplete Microscopic Colitis Drug: Budesonide granules 9 mg Drug: Placebo granules Phase 3

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Study Type : Interventional  (Clinical Trial)
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 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

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




Primary Outcome Measures :
  1. Rate of clinical remission [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Rate of clinical remission [ Time Frame: 2 weeks ]
  2. Rate of clinical remission [ Time Frame: 6 weeks ]
  3. Time to remission [ Time Frame: 8 weeks ]
  4. Number of formed/soft/watery stools per week [ Time Frame: 8 weeks ]
  5. Number of days with abdominal pain [ Time Frame: 8 weeks ]
  6. Number of days with urgency [ Time Frame: 8 weeks ]
  7. Rate of histological remission [ Time Frame: 8 weeks ]
  8. Physician's global assessment at final visit [ Time Frame: 8 weeks ]
  9. Quality of life [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142634


Locations
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Germany
Centre for Digestive Diseases
Hamburg, Germany, 20249
Sweden
University Hospital of Linköping, Dept. of Gastroenterology and Hepatology
Linköping, Sweden, 58185
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
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Principal Investigator: Andreas Münch, MD University Hospital of Linköping, Dept. of Gastroenterology and Hepatology

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Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT02142634    
Other Study ID Numbers: BUG-3/MIC
2013-001912-31 ( EudraCT Number )
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Colitis
Colitis, Microscopic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists