Long-Term Treatment of Collagenous Colitis With Budesonide | NCT00139165

Studies
Long-Term Treatment of Collagenous Colitis With Budesonide

NCT00139165

Sponsor

Bonderup, Ole K., M.D.

Status

Unknown status

Last Update Posted

Mar 6, 2008Estimated

Enrollment

Phase

Phase 3

Conditions

Collagenous Colitis

Interventions

Budesonide
sigmoidoscopy

Countries

Denmark

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Not provided

Completion Date

Mar 2006

First Submitted Date

Aug 29, 2005

First Submission Date that Met QC Criteria

Aug 29, 2005

First Posted Date

Aug 31, 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

Mar 3, 2008

Last Update Posted Date

Mar 6, 2008Estimated

Name	Class
AstraZeneca	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 aim of the trial is to examine the effect of budesonide treatment on collagenous colitis. All patients is treated for 6 weeks with budesonide and thereafter randomised to 24 weeks treatment with placebo or continued budesonide. The end poit is effect on clinical symptoms (number of daily stools)

Detailed Description

Not provided

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Budesonide	Drug	Capsule. Oral 6 mg o.d. for 24 weeks
sigmoidoscopy	Procedure	Sigmoidoscopy performed 2 times during the study period.

Measure	Description	Time Frame
Clinical symptoms

Measure	Description	Time Frame
Histological changes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological criteria of Collagenous colitis
Clinical activity (> 3 stools/day)

Exclusion Criteria:

Treatment of Collagenous colitis within the last 3 months

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
Ole K Bonderup, MD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of medical gastroenterology		Aalborg		9100	Denmark
Dept. of medical gastroenterology

Type	Date	Date Unknown
Release	Aug 1, 2018
Reset	Jan 17, 2019

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 1, 2018			Jan 17, 2019

Condition Browse Module

MeSH Terms

ID	Term
D046729	Colitis, Collagenous
D003967	Diarrhea

Ancestor Terms

ID	Term
D046728	Colitis, Microscopic
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019819	Budesonide
D012812	Sigmoidoscopy

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided