Budesonide Versus Mesalazine Versus Placebo in Lymphocyti... | NCT01209208

Studies
Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

NCT01209208

Sponsor

Dr. Falk Pharma GmbH

Status

Completed

Last Update Posted

Jul 26, 2017Actual

Enrollment

57Actual

Phase

Phase 3

Conditions

Lymphocytic Colitis

Interventions

Budesonide
Mesalamine
Placebo

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

ID	Type	Description	Link
2008-005994-36	EudraCT Number

Status Module

Record Verification Date

Jul 2017

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

May 2010

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Sep 23, 2010

First Submission Date that Met QC Criteria

Sep 24, 2010

First Posted Date

Sep 27, 2010Estimated

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

Jul 25, 2017

Last Update Posted Date

Jul 26, 2017Actual

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 purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of lymphocytic colitis.

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

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Budesonide	Drug: Budesonide
B	Experimental	Mesalazine	Drug: Mesalamine
C	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Budesonide	Drug	9 mg per day	A
Mesalamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of clinical remission		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients with histological improvement		8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
Symptoms and signs of indication of lymphocytic colitis

Exclusion Criteria:

Infectious diarrhoea,
Diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract or endoscopic-histological findings Celiac disease
Pregnancy or breast-feeding,
Participation in an other clinical trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 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, Professor	Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf, Hamburg, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf		Hamburg			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30195447	Derived	Miehlke S, Aust D, Mihaly E, Armerding P, Bohm G, Bonderup O, Fernandez-Banares F, Kupcinskas J, Munck LK, Rehbehn KU, Nacak T, Greinwald R, Munch A; BUG-1/LMC Study Group. Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis. Gastroenterology. 2018 Dec;155(6):1795-1804.e3. doi: 10.1053/j.gastro.2018.08.042. Epub 2018 Sep 7.

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

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473