To Evaluate the Efficacy and Safety in Subjects With Func... | NCT00323817

Studies
To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia

NCT00323817

Sponsor

Zeria Pharmaceutical

Status

Completed

Last Update Posted

May 28, 2015Estimated

Enrollment

282Estimated

Phase

Phase 2

Conditions

Functional Dyspepsia

Interventions

Z-338

Countries

Belgium

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

May 2015

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

Apr 2006

Primary Completion Date

Apr 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

May 8, 2006

First Submission Date that Met QC Criteria

May 8, 2006

First Posted Date

May 10, 2006Estimated

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

May 26, 2015

Last Update Posted Date

May 28, 2015Estimated

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

282Estimated

Name	Type	Description	Arm Group Labels	Other Names
Z-338	Drug

Measure	Description	Time Frame
Global subject Outcome Assessment		12 month

Measure	Description	Time Frame
Individual symptom		12 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects presenting diagnosis of FD as defined by the Rome II
Subjects presenting postprandial fullness and/or Early satiety should be the most bothersome symptom

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 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
Jan Tack, PhD, MD	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leuven University		Leuven			Belgium

Intervention Browse Module

MeSH Terms

ID	Term
C410959	Z 338

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided