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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Archimedes Development Ltd
Sponsor:
Information provided by (Responsible Party):
Archimedes Development Ltd
ClinicalTrials.gov Identifier:
NCT01698645
First received: October 1, 2012
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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 Intervention
Breakthrough Cancer Pain
Drug: PecFent® (fentanyl) nasal spray

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Archimedes Development Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Satisfaction will be assessed using a 4-point Likert scale.


Estimated Enrollment: 150
Study Start Date: September 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PecFent® Drug: PecFent® (fentanyl) nasal spray

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cancer patients with breakthrough pain

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698645

Contacts
Contact: Yolanda Riesgo, MD + 34 913510373 yolandariesgo@archimedespharma.com

Locations
Spain
Hospital 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Hernan Cortes, MD    + 34 913 908 349    hcortes.hdoc@salud.madrid.org   
Principal Investigator: Hernan Cortes, MD         
Sponsors and Collaborators
Archimedes Development Ltd
  More Information

No publications provided

Responsible Party: Archimedes Development Ltd
ClinicalTrials.gov Identifier: NCT01698645     History of Changes
Other Study ID Numbers: CP070/12
Study First Received: October 1, 2012
Last Updated: July 10, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Archimedes Development Ltd:
quality of life
PecFent
Lazanda
fentanyl
intranasal
breakthrough cancer pain

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

ClinicalTrials.gov processed this record on September 11, 2014