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Phase IV Registry Study of RELIEF (Rapid Evaluation of Lifestyle, Independence, and Elimination of Breakthrough Cancer Pain with Freedom from Oral Discomfort Through the Use of Abstral® (fentanyl) Sublingual Tablets)

Overview

This Observational Registry study is a post-marketing, single arm, open label, multicenter trial 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.

Eligibility

General Criteria:

Ages Eligible for Study:   Eighteen (18) Years and Older
Gender Eligible for Study:   Male and Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients will be included in the study based on the following 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:

Patients will be excluded in the study based on the following 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.

For more detailed criteria, eligibility, and trial specifics on ClinicalTrials.gov, please click here.

ClinicalTrials.gov Identifier NCT01936636