Suspended
QualipecA 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)
What is being collected
Drug Data
Collected from today forward - ProspectiveDrug
Who is being recruted
Over 18 Years
+2 Eligibility Criteria
How is the trial designed
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Observational
Study Start: September 2012
Summary
Principal SponsorArchimedes Development Ltd
Study ContactYolanda Riesgo, MDMore contacts
Last updated: July 11, 2013Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorArchimedes Development Ltd
Study ContactYolanda Riesgo, MDMore contacts
Last updated: July 11, 2013Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
2 inclusion criteria required to participate
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
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
SuspendedOne Study Center