Patient Satisfaction and Quality of Life Impact - PecFent®

Breakthrough Cancer Pain Clinical Trial

— Qualipec  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01693328
• Other study ID #: CP057/11
• Status: Recruiting
• Phase: N/A
• First received: September 20, 2012
• Last updated: January 14, 2014
• Start date: September 2012

Study information

• Verified date: January 2014
• Source: Archimedes Development Ltd
• Contact: Sylvie Allouche, MD
• Phone: +33155702320
• Email: sylvieallouchecovarrubias[@]archimedespharma.com
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breakthrough Cancer Pain
• Breakthrough Pain

Intervention

Drug:
• PecFent® (fentanyl) nasal spray

Locations

Country	Name	City	State
France	Centre Léon-Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Archimedes Development Ltd

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction	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	No