- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01693328
Patient Satisfaction and Quality of Life Impact - PecFent® (Qualipec)
January 14, 2014 updated by: Archimedes Development Ltd
A French, 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)
300
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
- Name: Sylvie Allouche, MD
- Phone Number: +33155702320
- Email: sylvieallouchecovarrubias@archimedespharma.com
Study Locations
-
-
-
Lyon, France
- Recruiting
- Centre Leon-Berard
-
Principal Investigator:
- Jérôme FAYETTE, MD
-
Contact:
- Jerome Fayette, MD
- Phone Number: +33487785451
- Email: jerome.fayette@lyon.unicancer.fr
-
-
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
18 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®
|
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 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 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
Investigators
- Principal Investigator: Alain Serrie, MD, Head of Pain Federation - Palliative Medicine Lariboisiere Hospital, Paris France
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)
March 1, 2014
Study Registration Dates
First Submitted
September 20, 2012
First Submitted That Met QC Criteria
September 24, 2012
First Posted (Estimate)
September 26, 2012
Study Record Updates
Last Update Posted (Estimate)
January 15, 2014
Last Update Submitted That Met QC Criteria
January 14, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP057/11
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.
Clinical Trials on Breakthrough Cancer Pain
-
Kyowa Kirin Co., Ltd.Completed
-
University Hospital, Basel, SwitzerlandTerminatedCancer: Breakthrough Pain | Cancer: Extreme Pain on MovementSwitzerland
-
Kyowa Kirin Co., Ltd.Completed
-
Aziende Chimiche Riunite Angelini Francesco S.p.ATerminatedBreakthrough Cancer PainPoland
-
TakedaCompletedBreakthrough Cancer PainUnited Kingdom, France, Denmark, Greece, Ireland, Norway, Sweden
-
CephalonTerminatedBreakthrough Pain | Cancer PainSpain, Germany, France, Ireland, Italy, Poland, United Kingdom
-
Seoul National UniversityWithdrawnBreakthrough Pain | Cancer Pain
-
A.Menarini Asia-Pacific Holdings Pte LtdCompletedBreakthrough Cancer PainKorea, Republic of
-
TakedaCompletedBreakthrough Cancer PainSpain
-
Chang Gung Memorial HospitalTTY BiopharmCompletedBreakthrough Cancer PainTaiwan
Clinical Trials on PecFent® (fentanyl) nasal spray
-
Archimedes Development LtdUnknownBreakthrough Cancer PainSpain
-
VistaGen Therapeutics, Inc.TerminatedSocial Anxiety DisorderUnited States
-
VistaGen Therapeutics, Inc.RecruitingSocial Anxiety DisorderUnited States
-
VistaGen Therapeutics, Inc.CompletedSocial Anxiety DisorderUnited States
-
Mylan Pharmaceuticals IncCompletedTreatment of the Signs and Symptoms of Seasonal Allergic Rhinitis
-
University of ChicagoMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.Withdrawn
-
Viiral Nordic ABCompleted
-
Imperial College LondonGlaxoSmithKlineCompleted
-
Oyster Point Pharma, Inc.CompletedDry Eye DiseaseUnited States
-
Lallemand Pharma AGNot yet recruitingRhinosinusitis Chronic | Microbiome