Comparison of Olanzapine and Metoclopramide For Treatment... | NCT01148264

Studies
Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis

NCT01148264

Sponsor

Karin Jordan

Status

Terminated

Last Update Posted

May 11, 2016Estimated

Enrollment

23Actual

Phase

Phase 2

Conditions

Emesis

Interventions

olanzapine
metoclopramide

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
2010-018665-30	EudraCT Number

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

poor enrolment

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jun 21, 2010

First Submission Date that Met QC Criteria

Jun 21, 2010

First Posted Date

Jun 22, 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

May 10, 2016

Last Update Posted Date

May 11, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment of break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy. Efficacy will be assessed using a modified MASCC questionaire with a visual analog scale.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
olanzapine	Experimental		Drug: olanzapine
metoclopramide	Active Comparator		Drug: metoclopramide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
olanzapine	Drug	1x10mg per day for three days	olanzapine	Zyprexa

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical benefit rate	no vomitus, no further rescue medication, nausea < 25mm on the visual analog scale (VAS) or reduction on the VAS of >50%	three days

Secondary Outcomes

Measure	Description	Time Frame
safety	according to NCI-CTC-AE version4.0	five days
Quality of life	using EORTC-QLQ-C30	5 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy defined as vomitus or nausea>25mm on VAS
signed IC

Exclusion Criteria:

psychiatric disorders
drug abuse
pregnancy
high dose chemotherapy
treatment with other antiemetic drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karin Jordan, MD	Martin-Luther-University Halle-Wittenberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Martin-Luther-University Halle-Wittenberg, Department for Oncology and Hematology, Ernst-Grube-Strasse 40		Halle	Saxony-Anhalt	06097	Germany

Condition Browse Module

MeSH Terms

ID	Term
D014839	Vomiting

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077152	Olanzapine
D008787	Metoclopramide

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided