Patient Satisfaction and Quality of Life Impact - PecFent® | NCT01698645

Studies
Patient Satisfaction and Quality of Life Impact - PecFent®

NCT01698645

Sponsor

Archimedes Development Ltd

Status

Unknown status

Last Update Posted

Jul 11, 2013Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Breakthrough Cancer Pain

Interventions

PecFent® (fentanyl) nasal spray

Countries

Spain

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

Jul 2013

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

Dec 2014Estimated

Completion Date

Not provided

First Submitted Date

Oct 1, 2012

First Submission Date that Met QC Criteria

Oct 2, 2012

First Posted Date

Oct 3, 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

Jul 10, 2013

Last Update Posted Date

Jul 11, 2013Estimated

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

150Estimated

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 breakthrough pain (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
Yolanda Riesgo, MD	Contact	+ 34 913510373		yolandariesgo@archimedespharma.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital 12 de Octubre	Recruiting	Madrid		28041	Spain

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