Effentora® in Clinical Practice - a Non-interventional St... | NCT01400854

Studies
Effentora® in Clinical Practice - a Non-interventional Study to Evaluate Satisfaction and Tolerability

NCT01400854

Sponsor

Cephalon

Status

Completed

Last Update Posted

Oct 24, 2012Estimated

Enrollment

600Actual

Phase

Not provided

Conditions

Cancer
Pain

Interventions

Effentora®

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

Status Module

Record Verification Date

Oct 2012

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 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Jul 21, 2011

First Submission Date that Met QC Criteria

Jul 21, 2011

First Posted Date

Jul 22, 2011Estimated

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

Oct 23, 2012

Last Update Posted Date

Oct 24, 2012Estimated

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

Aim of this non-interventional study is to investigate the tolerability of Effentora® in cancer pain patients with breakthrough pain under real-life conditions in clinical practice.

Detailed Description

In addition to the effectiveness of Effentora® therapy, safety, general feasibility and the impact of therapy on the patients' quality of life are of interest.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Effentora®		Single group prospective treatment cohort	Drug: Effentora®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Effentora®	Drug	prescribed as per local Summary of Product Characteristics (SmPC) for 4 weeks duration	Effentora®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain relief	to show adequate pain relief within 10 minutes	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
occurrence of adverse events	document the tolerability of Effentora®	4 weeks
Change in level of breakthrough pain	pursue the possible changes in the history of breakthrough pain during treatment with Effentora

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

decision to start treatment with Effentora
prescription in accordance with Summary of Product Characteristics (SmPC)
personally signed and dated Informed Consent document

Exclusion Criteria:

any subject considered unsuitable according to SmPC

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

Adult cancer patients (in- or out-patients) that are suffering from breakthrough pain

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Department	Cephalon	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cephalon GmbH		Munich	Bavaria	80339	Germany

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided