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. Identifier: NCT01698645
Recruitment Status : Unknown
Verified July 2013 by Archimedes Development Ltd.
Recruitment status was:  Recruiting
First Posted : October 3, 2012
Last Update Posted : July 11, 2013
Information provided by (Responsible Party):
Archimedes Development Ltd

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 Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Study Start Date : September 2012
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fentanyl

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01698645

Contact: Yolanda Riesgo, MD + 34 913510373

Hospital 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Hernan Cortes, MD    + 34 913 908 349   
Principal Investigator: Hernan Cortes, MD         
Sponsors and Collaborators
Archimedes Development Ltd

Responsible Party: Archimedes Development Ltd Identifier: NCT01698645     History of Changes
Other Study ID Numbers: CP070/12
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

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