OD vs. TID Dosing With Mesalazine Granules in Active Ulce... | NCT00449722

Studies
OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis

NCT00449722

Sponsor

Dr. Falk Pharma GmbH

Status

Completed

Last Update Posted

Jan 21, 2016Estimated

Enrollment

380

Phase

Phase 3

Conditions

Ulcerative Colitis

Interventions

mesalazine

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
2004-001216-31

Status Module

Record Verification Date

Jan 2016

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 2005

Primary Completion Date

Not provided

Completion Date

Jun 2006Actual

First Submitted Date

Mar 20, 2007

First Submission Date that Met QC Criteria

Mar 20, 2007

First Posted Date

Mar 21, 2007Estimated

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, 2016

Last Update Posted Date

Jan 21, 2016Estimated

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

To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative 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

380

Name	Type	Description	Arm Group Labels	Other Names
mesalazine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of clinical remission

Secondary Outcomes

Measure	Description	Time Frame
Rate of clinical response
time to resolution of symptoms
rate of endoscopical remission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria (main):

Active ulcerative colitis except proctitis, i.e. inflammation minimal 15cm ab ano, confirmed by endoscopy and histology
Established or new diagnosis
Disease activity at baseline: Clinical Activity Index (CAI) >4 and Endoscopic Index (EI) >= 4

Exclusion Criteria (main):

Crohn's disease
Toxic megacolon
Present or past colorectal cancer
Symptomatic gastrointestinal disease
Serious secondary disease(s)
Baseline stool positive for germs causing bowel disease
Immunosuppressants within 3 months and/or corticosteroids within 1 month prior to baseline
Current relapse occurred under maintenance treatment with >2g/day mesalazine
Serum creatinine >= 1.2x upper limit of normal (ULN) and creatinine clearance < 60 ml/min per 1.73 m2
Serum transaminase (ALT and/or AST), and/or alkaline phosphatase >= 2x ULN

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 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
Wolfgang Kruis, Professor	Evangelisches Krankenhaus Kalk, Cologne, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Evangelisches Krankenhaus Kalk		Cologne		51103	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18832520	Result	Kruis W, Kiudelis G, Racz I, Gorelov IA, Pokrotnieks J, Horynski M, Batovsky M, Kykal J, Boehm S, Greinwald R, Mueller R; International Salofalk OD Study Group. Once daily versus three times daily mesalazine granules in active ulcerative colitis: a double-blind, double-dummy, randomised, non-inferiority trial. Gut. 2009 Feb;58(2):233-40. doi: 10.1136/gut.2008.154302. Epub 2008 Oct 2.

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

ID	Term
D062368	meta-Aminobenzoates
D062365	Aminobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic