Patient Satisfaction and Quality of Life Impact - PecFent® | NCT01693328

Studies
Patient Satisfaction and Quality of Life Impact - PecFent®

NCT01693328

Sponsor

Archimedes Development Ltd

Status

Unknown status

Last Update Posted

Jan 15, 2014Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Breakthrough Cancer Pain

Interventions

PecFent® (fentanyl) nasal spray

Countries

France

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Mar 2014Estimated

Completion Date

Not provided

First Submitted Date

Sep 20, 2012

First Submission Date that Met QC Criteria

Sep 24, 2012

First Posted Date

Sep 26, 2012Estimated

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 14, 2014

Last Update Posted Date

Jan 15, 2014Estimated

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

National multicenter, prospective, observational study in cancer patients with chronic background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic condition by a specialist in the treatment of cancer pain conditions.

• Study objectives include assessment of early treatment satisfaction.

Detailed Description

Not provided

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

300Estimated

Label	Type	Description	Intervention Names
PecFent®			Drug: PecFent® (fentanyl) nasal spray

Name	Type	Description	Arm Group Labels	Other Names
PecFent® (fentanyl) nasal spray	Drug		PecFent®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Satisfaction	Satisfaction will be assessed using a 4-point Likert scale.	Satisfaction will be assessed approximately 1 hour after each BTPc episode treated with PecFent® from completion of titration through Day 7

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (aged ≥18 years) with cancer
Taking at least 60 mg of oral morphine sulfate or equivalent per day for chronic background pain

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

Cancer patients with breakthrough pain

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sylvie Allouche, MD	Contact	+33155702320		sylvieallouchecovarrubias@archimedespharma.com

Overall Officials

Name	Affiliation	Role
Alain Serrie, MD	Head of Pain Federation - Palliative Medicine Lariboisiere Hospital, Paris France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Léon-Bérard	Recruiting	Lyon			France

Intervention Browse Module

MeSH Terms

ID	Term
D005283	Fentanyl
D059085	Nasal Sprays

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000336	Aerosols

Browse Leaves

Not provided

Browse Branches

Not provided