Patient Satisfaction and Quality of Life Impact - PecFent® (Qualipec)

July 10, 2013 updated by: Archimedes Development Ltd

A Spanish , Multicentre, Open-label, Observational Study to Assess Quality of Life and Satisfaction in Subjects Taking PecFent® for the Treatment of Breakthrough Cancer Pain (BTPc)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital 12 de Octubre
        • Contact:
        • Principal Investigator:
          • Hernan Cortes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cancer patients with breakthrough pain

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PecFent®
Drug: PecFent® (fentanyl) nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Archimedes Development Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

October 1, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP070/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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