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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01936636
Other study ID # RELIEF
Secondary ID
Status Completed
Phase N/A
First received September 2, 2013
Last updated November 3, 2015
Start date October 2013
Est. completion date June 2015

Study information

Verified date November 2015
Source Galena Biopharma, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 164
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Time Perspective: Prospective


Intervention

Drug:
Fentanyl


Locations

Country Name City State
United States Akron General Medical Center Akron Ohio
United States Interventional Spine and Pain Management Atlanta Georgia
United States Physiatry Consultants Bay City Michigan
United States Michigan Interventional Pain Center Brownstown Michigan
United States Coastal Pain Research Carlsbad California
United States PRIDE Dallas Texas
United States Western Connecticut Health Network, Danbury Hospital Danbury Connecticut
United States Navajo Road Pain Management Center El Cajon California
United States California Cancer Associates for Research and Excellence, Inc. Fresno California
United States The West Clinic Comprehensive Breast Center Germantown Tennessee
United States Red Rocks Center for Rehabilitation Golden Colorado
United States Interventional Pain Management Irvine California
United States Columbia Basin Hematology & Oncology Kennewick Washington
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 Physicians Pain Specialists of Alabama, P.C. Mobile Alabama
United States J. Fred Stoner, MD New Castle Pennsylvania
United States Fountain Medical Group New York New York
United States Upper East Side Pain Medicine, P.C. New York New York
United States Cancer Treatment Centers of America Newnan Georgia
United States Pain Management Institute Overland Park Kansas
United States Pain Centers Nationwide Peoria Arizona
United States Florida Cancer Care Plantation Florida
United States Jerrold Rosenberg, MD Providence Rhode Island
United States Glenn Saperstein, D.O., LLC Saginaw Michigan
United States Pain Institute of Santa Monica Santa Monica California
United States Valley Pain Consultants Scottsdale Arizona
United States Advanced Physical Medicine St. Clair Shores Michigan
United States Pain Management Associates of CT, PC Stamford Connecticut
United States Comprehensive Pain Management Syosset New York
United States Cancer Treatment Centers of America Tulsa Oklahoma
United States Michigan Spine & Pain West Bloomfield Michigan
United States APWI Williamsville New York
United States Progressive Pain Solutions Wind Gap Pennsylvania
United States Randy Scharlach, MD Woodland Hills California

Sponsors (1)

Lead Sponsor Collaborator
Galena Biopharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life Primary:
To compare self reported TIRF REMS Access-enrolled patient experience with BTcP at baseline (before using Abstral) to their experience after reaching a maintenance dose of Abstral
Characterize the effectiveness of treatment with Abstral in select pain and quality-of-life (QoL) domains
Abstral impact on pain interference with daily activities, somnolence, and oral health
One month No
Secondary Rapidity of BTcP Trends in improvement or deterioration in these values during treatment and across the dosage groups will be described. one month No
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