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

Completed

Conditions studied: Quality of Life, Breakthrough Cancer Pain

In brief

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.

Key facts

Study ID

NCT01936636

Run by

Galena Biopharma, Inc.

People needed

164

Starts

2013-10-01

Expected to finish

2015-06-01

Last updated by the study team

2015-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients 18 years of age and older with breakthrough cancer pain who are registered in the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program and receiving Abstral® under the direction of a TIRF REMS Access program-registered physician are eligible for the study.
• Patients or their proxy with a witness must be able to sign written informed consent to participate in the study; and the patient may also use a proxy caregiver to assist in the completion of the study questionnaires.

You may not qualify if…

• No patient can be enrolled who has not been prescribed Abstral for BTcP in compliance with Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program guidelines.
• No patient may be enrolled who has a contraindication to receiving Abstral or who is pregnant.

Where it is running

• Physicians Pain Specialists of Alabama, P.C. — Mobile, Alabama, United States
• Pain Centers Nationwide — Peoria, Arizona, United States
• Valley Pain Consultants — Scottsdale, Arizona, United States
• Coastal Pain Research — Carlsbad, California, United States
• Navajo Road Pain Management Center — El Cajon, California, United States
• California Cancer Associates for Research and Excellence, Inc. — Fresno, California, United States
• Interventional Pain Management — Irvine, California, United States
• Alexander Ford, MD — Los Angeles, California, United States
• Cancer Care Institute — Los Angeles, California, United States
• Pete J. Ruane, MD, Inc. — Los Angeles, California, United States
• Pain Institute of Santa Monica — Santa Monica, California, United States
• Randy Scharlach, MD — Woodland Hills, California, United States
• Red Rocks Center for Rehabilitation — Golden, Colorado, United States
• Western Connecticut Health Network, Danbury Hospital — Danbury, Connecticut, United States
• Pain Management Associates of CT, PC — Stamford, Connecticut, United States
• Florida Cancer Care — Plantation, Florida, United States
• Interventional Spine and Pain Management — Atlanta, Georgia, United States
• Cancer Treatment Centers of America — Newnan, Georgia, United States
• Pain Management Institute — Overland Park, Kansas, United States
• Physiatry Consultants — Bay City, Michigan, United States
• Michigan Interventional Pain Center — Brownstown, Michigan, United States
• Glenn Saperstein, D.O., LLC — Saginaw, Michigan, United States
• Advanced Physical Medicine — Saint Clair Shores, Michigan, United States
• Michigan Spine & Pain — West Bloomfield, Michigan, United States
• Fountain Medical Group — New York, New York, United States

Full record on ClinicalTrials.gov

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