NCT01693328

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

January 15, 2014

Status Verified

January 1, 2014

Enrollment Period

1.5 years

First QC Date

September 20, 2012

Last Update Submit

January 14, 2014

Conditions

Breakthrough Cancer Pain

Keywords

quality of lifePecFentLazandafentanylintranasalbreakthrough cancer pain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

PecFent®

Drug: PecFent® (fentanyl) nasal spray

Interventions

PecFent® (fentanyl) nasal sprayDRUG
PecFent®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients with breakthrough pain

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Léon-Bérard

Lyon, France

RECRUITING

MeSH Terms

Interventions

FentanylNasal Sprays

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAerosolsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Alain Serrie, MD

    Head of Pain Federation - Palliative Medicine Lariboisiere Hospital, Paris France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie Allouche, MD

CONTACT

+33155702320sylvieallouchecovarrubias@archimedespharma.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 26, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2014

Last Updated

January 15, 2014

Record last verified: 2014-01

Locations

FR(1)