NCT01936636

Observational Registry Study of Quality of Life When Treating BTcP With Abstral

Rapid Evaluation of Lifestyle, Independence, and Elimination of Breakthrough Cancer Pain With Freedom From Oral Discomfort Through the Use of Abstral® (Fentanyl) Sublingual Tablets

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 164 (actual)
• Sponsor: Galena Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Observational Registry study is designed to collect self-reported Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program-enrolled patient experience with breakthrough cancer pain (BTcP) as a result of treatment with Abstral® through the use of Quality of Life and pain measurement tools administered via questionnaire.

Detailed description

This is a post-marketing, single arm, open label multicenter trial to assess Abstral (fentanyl) Sublingual Tablets for breakthrough cancer pain (BTcP) in opioid-tolerant cancer patients. * Prior to study enrollment, patient enrollment in the TIRF REMS Access program must be confirmed. * Eligible patients will sign written informed consent. Patients or their proxy with a witness must be able to sign written informed consent to participate in the study; and the patient may use a proxy caregiver to assist in the completion of the study questionnaires. * Day 0, study site must enroll patient by completing a patient demographic profile (de-identified). * Day 0, patient will be instructed how to use the questionnaires. * Day 0, patient will complete the baseline questionnaire before leaving the physician office. * On study Days 14, 21, and 28 (±3 days) patient questionnaire will be completed by patient (or caregiver proxy) via secure online data entry portal. * For patients completing paper questionnaires, within 1 month of day 28, patient will return completed questionnaires via mail, fax or hand carried to the study site coordinator for processing. * Patient will be considered to have completed the study successfully once all completed questionnaires have been received by the CRO within appropriate time limits.

Conditions

• Quality of Life
• Breakthrough Cancer Pain

Interventions

Type	Name	Description
DRUG	Fentanyl

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-09-06
• Last updated: 2015-11-05

Locations

36 sites across 1 country: United States