Patient Satisfaction and Quality of Life Impact - PecFent®

• Conditions: Breakthrough Cancer Pain
• Interventions: Drug: PecFent® (fentanyl) nasal spray

• Registration Number: NCT01693328
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-26
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-15
• Primary Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PecFent®	PecFent® (fentanyl) nasal spray	-

Primary Outcome Measures

Name	Time	Method
Satisfaction	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.

Trial Locations

Locations (1)

Centre Léon-Bérard; 🇫🇷 Lyon, France