Budesonide Treatment for Lymphocytic Colitis | NCT00180050

Studies
Budesonide Treatment for Lymphocytic Colitis

NCT00180050

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Mar 30, 2010Estimated

Enrollment

40Estimated

Phase

Phase 3

Conditions

Microscopic 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

Jan 2002

Primary Completion Date

Aug 2006Actual

Completion Date

Aug 2007Actual

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
Dr. Falk Pharma GmbH	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

Detailed Description

The purpose of this study is to determine whether orale budesonide is effective in the treatment of 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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

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 weeks

Secondary Outcomes

Measure	Description	Time Frame
safety
quality of life
histological improvement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

lymphocytic colitis
diarrhea
effective contraception
written informed consent

Exclusion Criteria:

other forms if IBD
celiac disease
infectious colitis
history of colonic surgery
use of budesonide, 5-ASA, steroids within th previous 4 weeks
pregnancy, lactation

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
D046728	Colitis, Microscopic
D046730	Colitis, Lymphocytic

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