NCT00184171

Brief Summary

The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
terminated

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

November 1, 2001

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

8.8 years

First QC Date

September 10, 2005

Last Update Submit

January 20, 2015

Conditions

Colitis

Keywords

Microscopic colitisDrug treatmentDiarrhoea

Outcome Measures

Primary Outcomes (1)

  • Symptoms: Stool frequency and consistency

    September 2010: Patient's enrollment completed. Data analysis ongoing.

    2001 - 2011

Secondary Outcomes (1)

  • Histological findings in biopsies from colon

    2001 - 2011

Study Arms (3)

Budesonide

EXPERIMENTAL

Budesonide 9mg

Drug: Budesonide

bismuth

EXPERIMENTAL

Bismuth mixture

Drug: Bismuth

Fiber

SHAM COMPARATOR

Fiber preparation

Drug: Fiber

Interventions

BudesonideDRUG

Budesonide 9 mg

Budesonide
BismuthDRUG

Bismuth mixture

bismuth
FiberDRUG

Fiber for control

Fiber

Eligibility Criteria

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

You may qualify if:

  • Microscopic colitis verified with biopsies from the colon
  • Symptoms to such an extent that treatment is indicated
  • Age \> 17 years
  • Informed consent

You may not qualify if:

  • Previous treatment with any of the investigational drugs
  • Patients treated with ketoconazole
  • Pregnant and breast-feeding females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Aust-Agder Sentralsjukehus

Arendal, Norway

Location

Sykehuset Innlandet HF, Gjøvik

Gjøvik, 2819, Norway

Location

Sykehuset Innlandet, HF, Hamar

Hamar, Norway

Location

Sykehuset Innlandet HF, Lillehammer

Lillehammer, Norway

Location

Helse NordMøre og Romsdal

Molde, Norway

Location

Akershus Universitetssykehus

Nordbyhagen, Norway

Location

Aker sykehus

Oslo, Norway

Location

Rikshopitalet

Oslo, Norway

Location

St. Olavs Hospital

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

ColitisColitis, MicroscopicDiarrhea

Interventions

BudesonideBismuthDietary Fiber

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsElements, RadioactiveElementsInorganic ChemicalsMetals, HeavyRadioisotopesIsotopesMetalsDietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Per G Farup, PhD

    Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 16, 2005

Study Start

November 1, 2001

Primary Completion

September 1, 2010

Study Completion

October 1, 2014

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

NO(9)