NCT01901718

An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray.

An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray Compared to Actiq® for the Management of Breakthrough Pain in Chronic Pain Patients.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 4 (actual)
• Sponsor: International Clinical Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic pain patients who experience breakthrough pain in the background of controlled persistent pain with opioids will be followed for 3 months in order to assess the safety and titration trends in the clinical practice setting of a novel fentanyl sublingual spray (Subsys™) for the treatment of breakthrough pain.

Detailed description

Approximately 100 subjects across 10 centers throughout the United States will be enrolled into the study. Subjects who are currently taking Actiq® for their breakthrough pain and will be discontinued due to lack of efficacy, poor tolerability, patient or prescriber dissatisfaction and meet all other study inclusion criteria and none of the exclusion criteria will be candidates to receive a sublingual fentanyl spray (Subsys™). The total duration of the study for each subject will be no more than 4 months.

Conditions

• Breakthrough Pain

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2013-07-17
• Last updated: 2014-09-04

Locations

1 site across 1 country: United States