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Status unknownNCT01693328QualipecUpdated Jan 15, 2014

Patient Satisfaction and Quality of Life Impact - PecFent®

An observational study in Breakthrough Cancer Pain, sponsored by Archimedes Development Ltd. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-15.

Sponsored by Archimedes Development Ltd (part of Kyowa Kirin Co., Ltd.) · Observational

The sponsor has not verified this record recently (last verified Jan 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Breakthrough Cancer Pain

Keywords

  • quality of life
  • PecFent
  • Lazanda
  • fentanyl
  • intranasal
  • breakthrough cancer pain
03

In context

Lead sponsor

Archimedes Development Ltd is the lead sponsor of 5 studies on the registry; none are open to participants now.

First submitted before Archimedes Development Ltd became part of Kyowa Kirin Co., Ltd..

Browse Archimedes Development Ltd studies →All Kyowa Kirin Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cancer patients with breakthrough pain

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)

Groups and cohorts

  • PecFent®

    Drug: PecFent® (fentanyl) nasal spray

06

What researchers measure

Primary outcomes

  1. Satisfaction

    Satisfaction will be assessed using a 4-point Likert scale.

    Time frame: Satisfaction will be assessed approximately 1 hour after each BTPc episode treated with PecFent® from completion of titration through Day 7

07

Study locations

1 of 1 sites recruiting
  • Centre Léon-Bérard
    Lyon, France
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2012 and a primary completion of Mar 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2012
First posted
Sep 26, 2012
Start
Sep 2012
Primary completionEst.
Mar 2014
Last update
Jan 15, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01693328
Lead sponsor
Archimedes Development Ltd
Responsible party
Sponsor
First posted
Sep 26, 2012
Start date
Sep 2012
Primary completion
Mar 2014 (estimated)
Last update
Jan 15, 2014

Study contacts

Sylvie Allouche, MD
Contact
sylvieallouchecovarrubias@archimedespharma.com
+33155702320
Alain Serrie, MD
principal investigator · Head of Pain Federation - Palliative Medicine Lariboisiere Hospital, Paris France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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