Text Size

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

This study is currently recruiting participants.
Verified October 2012 by Archimedes Development Ltd
Sponsor:
Information provided by (Responsible Party):
Archimedes Development Ltd
ClinicalTrials.gov Identifier:
NCT01698645
First received: October 1, 2012
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
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
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: October 2, 2012
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:
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on June 18, 2013