Budesonide for Maintenance Treatment of Collagenous Colitis | NCT00180076

Studies
Budesonide for Maintenance Treatment of Collagenous Colitis

NCT00180076

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Mar 30, 2010Estimated

Enrollment

75Estimated

Phase

Phase 3

Conditions

Collagenous Colitis

Interventions

Budesonide

Countries

Germany

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

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2008

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 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

Mar 29, 2010

Last Update Posted Date

Mar 30, 2010Estimated

Name	Class
AstraZeneca	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

Detailed Description

The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous 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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Name	Type	Description	Arm Group Labels	Other Names
Budesonide	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients in clinical remission after 6 months

Secondary Outcomes

Measure	Description	Time Frame
time to relapse
safety
quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

collagenous colitis
diarrhea
written informed consent

Exclusion Criteria:

infectious causes for diarrhea
other inflammatory bowel diseases
history of colonic surgery
celiac disease
malignancies
severe concomitant diseases
use of budesonide, steroids, mesalazine within the previous 2 weeks
known intolerance to budesonide
history of lack of response to budesonide
pregnancy,lactation
drug and/or alcohol abuse
lack of compliance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephan Miehlke, Prof.	Medical Department I, Technical University Hospital, Dresden, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Department I, Technical University Hospital		Dresden		01307	Germany

Condition Browse Module

MeSH Terms

ID	Term
D046729	Colitis, Collagenous
D046728	Colitis, Microscopic

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019819	Budesonide

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided