Treatment of Microscopic Colitis | NCT00184171

Studies
Treatment of Microscopic Colitis

NCT00184171

Sponsor

Norwegian University of Science and Technology

Status

Terminated

Last Update Posted

Jan 21, 2015Estimated

Enrollment

105Actual

Phase

Not Applicable

Conditions

Colitis

Interventions

Budesonide
Bismuth
Fiber

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient data quality

Expanded Access Info

Start Date

Nov 2001

Primary Completion Date

Sep 2010Actual

Completion Date

Oct 2014Actual

First Submitted Date

Sep 10, 2005

First Submission Date that Met QC Criteria

Sep 15, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2015

Last Update Posted Date

Jan 21, 2015Estimated

Name	Class
AstraZeneca	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This randomized, controlled, open study compares the effects of 8 weeks' treatment with Budesonide, Bismuth and fiber on symptoms and histological findings in patients with microscopic colitis (both collagenous colitis and lymphocytic colitis).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Budesonide	Experimental	Budesonide 9mg	Drug: Budesonide
bismuth	Experimental	Bismuth mixture	Drug: Bismuth
Fiber	Sham Comparator	Fiber preparation	Drug: Fiber

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Budesonide	Drug	Budesonide 9 mg	Budesonide
Bismuth

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptoms: Stool frequency and consistency	September 2010: Patient's enrollment completed. Data analysis ongoing.	2001 - 2011

Secondary Outcomes

Measure	Description	Time Frame
Histological findings in biopsies from colon	Patient's enrollment completed. Data analysis ongoing.	2001 - 2011

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Per G Farup, PhD	Norwegian University of Science and Technology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aust-Agder Sentralsjukehus		Arendal			Norway
Sykehuset Innlandet HF, Gjøvik

Condition Browse Module

MeSH Terms

ID	Term
D003092	Colitis
D046728	Colitis, Microscopic
D003967	Diarrhea

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D003108	Colonic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019819	Budesonide
D001729	Bismuth
D004043	Dietary Fiber

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided