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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01693328
Recruitment Status : Unknown
Verified January 2014 by Archimedes Development Ltd.
Recruitment status was:  Recruiting
First Posted : September 26, 2012
Last Update Posted : January 15, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Breakthrough Cancer Pain Drug: PecFent® (fentanyl) nasal spray

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Study Start Date : September 2012
Estimated Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fentanyl
U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients with breakthrough pain

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693328

Contact: Sylvie Allouche, MD +33155702320 sylvieallouchecovarrubias@archimedespharma.com

Centre Léon-Bérard Recruiting
Lyon, France
Contact: Jerome Fayette, MD    +33487785451    jerome.fayette@lyon.unicancer.fr   
Principal Investigator: Jerome Fayette, MD         
Sponsors and Collaborators
Archimedes Development Ltd
Principal Investigator: Alain Serrie, MD Head of Pain Federation - Palliative Medicine Lariboisiere Hospital, Paris France
More Information

Responsible Party: Archimedes Development Ltd
ClinicalTrials.gov Identifier: NCT01693328     History of Changes
Other Study ID Numbers: CP057/11
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: January 15, 2014
Last Verified: January 2014

Keywords provided by Archimedes Development Ltd:
quality of life
breakthrough cancer pain

Additional relevant MeSH terms:
Cancer Pain
Breakthrough Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General