Patient Satisfaction and Quality of Life Impact - PecFent®
Qualipec
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)
1 other identifier
observational
150
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedJuly 11, 2013
July 1, 2013
2.2 years
October 1, 2012
July 10, 2013
Conditions
Keywords
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 breakthrough pain (BTPc) episode treated with PecFent® from completion of titration through Day 7
Study Arms (1)
PecFent®
Interventions
Eligibility Criteria
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)
Hospital 12 de Octubre
Madrid, 28041, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2012
First Posted
October 3, 2012
Study Start
September 1, 2012
Primary Completion
December 1, 2014
Last Updated
July 11, 2013
Record last verified: 2013-07