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Status unknownNCT01698645QualipecUpdated Jul 11, 2013

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 Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-11.

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

The sponsor has not verified this record recently (last verified Jul 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
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
150 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 breakthrough pain (BTPc) episode treated with PecFent® from completion of titration through Day 7

07

Study locations

1 of 1 sites recruiting
  • Hospital 12 de Octubre
    Madrid, 28041, Spain
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01698645
Lead sponsor
Archimedes Development Ltd
Responsible party
Sponsor
First posted
Oct 3, 2012
Start date
Sep 2012
Primary completion
Dec 2014 (estimated)
Last update
Jul 11, 2013

Study contacts

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

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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