NCT02142634

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2014

Longer than P75 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

5.8 years

First QC Date

May 14, 2014

Last Update Submit

July 21, 2020

Conditions

Incomplete Microscopic Colitis

Outcome Measures

Primary Outcomes (1)

  • Rate of clinical remission

    8 weeks

Secondary Outcomes (9)

  • Rate of clinical remission

    2 weeks

  • Rate of clinical remission

    6 weeks

  • Time to remission

    8 weeks

  • Number of formed/soft/watery stools per week

    8 weeks

  • Number of days with abdominal pain

    8 weeks

  • +4 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Budesonide granules 9 mg

Drug: Budesonide granules 9 mg

B

PLACEBO COMPARATOR

Placebo granules

Drug: Placebo granules

Interventions

Budesonide granules 9 mgDRUG

per day

A
Placebo granulesDRUG

per day

B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically established diagnosis of incomplete microscopic colitis (MCi)
  • History of chronic non-bloody, watery diarrhoea
  • Clinically active disease

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for Digestive Diseases

Hamburg, 20249, Germany

Location

University Hospital of Linköping, Dept. of Gastroenterology and Hepatology

Linköping, 58185, Sweden

Location

Study Officials

  • Andreas Münch, MD

    University Hospital of Linköping, Dept. of Gastroenterology and Hepatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 20, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

DE(1)SE(1)