Two Doses Mesalazine Granules Versus Placebo for the Prev... | NCT01038739

Studies
Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis

NCT01038739

Sponsor

Dr. Falk Pharma GmbH

Status

Terminated

Last Update Posted

Jul 21, 2017Actual

Enrollment

330Actual

Phase

Phase 3

Conditions

Diverticulitis

Interventions

Mesalazine
Mesalazine
Placebo

Countries

United States

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
2009-015158-39	Other Identifier	Eudract

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Stopped due to futility.

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Dec 22, 2009

First Submission Date that Met QC Criteria

Dec 23, 2009

First Posted Date

Dec 24, 2009Estimated

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

Jun 21, 2017

Certification/Extension First Submitted that Passed QC Review

Jun 21, 2017

Certification/Extension First Posted Date

Jun 26, 2017Actual

Last Update Submitted Date

Jul 20, 2017

Last Update Posted Date

Jul 21, 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 the study is to determine which dose of mesalazine granules compared to placebo is more effective in the prevention of recurrence of disease.

Detailed Description

The primary purpose of the study is to demonstrate the superiority of mesalazine granules compared to placebo in terms of the two primary efficacy variables 'proportion of recurrence-free patients within 48 weeks' and 'proportion of recurrence-free patients within 96 weeks'.

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

330Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
A	Experimental	Drug: Mesalazine
B	Experimental	Drug: Mesalazine
C	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mesalazine	Drug	3 g per day	B
Mesalazine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of recurrence-free patients at 48 weeks and at 96 weeks:		48/96 weeks

Secondary Outcomes

Measure	Description	Time Frame
Time to recurrence		48/96 weeks
Occurrence of diverticulitis-associated fever		48/96 weeks
Number of days with left lower quadrant pain

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of left-sided uncomplicated diverticular disease confirmed by computed tomography
Presence of at least one diverticulum of the left colon
Most recent attack of left-sided uncomplicated diverticulitis responding to antibiotics and/or dietary modification within the last 6 months
C-reactive protein (CRP) > upper limit of normal (ULN) or leucocytosis at the start of the most recent attack

Exclusion Criteria:

Complicated diverticular disease
Right-sided diverticulitis
Previous colonic surgery
Presence of symptomatic organic disease of the gastrointestinal tract
Active colorectal cancer or a history of colorectal cancer
Hemorrhagic diathesis
Active peptic ulcer disease, local intestinal infection
Asthma if careful medical monitoring is not ensured
Abnormal hepatic function or liver cirrhosis
Abnormal renal function

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 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
Wolfgang Kruis, Professor	Evang. Krankenhaus Kalk, Medical department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
United Medical Research		New Smyrna Beach	Florida	32168	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28543263	Result	Kruis W, Kardalinos V, Eisenbach T, Lukas M, Vich T, Bunganic I, Pokrotnieks J, Derova J, Kondrackiene J, Safadi R, Tuculanu D, Tulassay Z, Banai J, Curtin A, Dorofeyev AE, Zakko SF, Ferreira N, Bjorck S, Diez Alonso MM, Makela J, Talley NJ, Dilger K, Greinwald R, Mohrbacher R, Spiller R. Randomised clinical trial: mesalazine versus placebo in the prevention of diverticulitis recurrence. Aliment Pharmacol Ther. 2017 Aug;46(3):282-291. doi: 10.1111/apt.14152. Epub 2017 May 23.
28707796

ID	Term
D000076385	Diverticular Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

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