Study identification

PURI

https://redirect.ema.europa.eu/resource/28445

EU PAS number

EUPAS10402

Study ID

28445

Official title and acronym

Pharmaco-epidemiologic study on occurrence of adverse events

DARWIN EU® study

No

Study countries

France

Study description

Effentora® is an oral, rapidly dissolving opioid tablet indicated for the treatment of breakthrough pain in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. Following centralized approval of Effentora®, the Sponsor has conducted a post-marketing study of Effentora® as part of the Risk Management Plan.The primary objective of this study was to estimate the rates of AEs occuring during Effentora® treatment, over the first 3 months following initiation, in a real-life setting. The secondary objectives of the study were: a) to describe Effentora® usage, b) to describe the characteristics of "primary care" population, c) to evaluate the effectiveness of Effentora® in treating pain, d) to evaluate physician and patient satisfaction with the educational brochures that are part of the EU RMP.The study was designed as a prospective, multicenter, longitudinal cohort of Effentora®-naive patients in France during 2013-2014. Specialist physicians and general practitioners were contacted and invited to particiate in the study. Inclusion criteria for patients were the following: a) patients naive to Effentora® treatment, b) patients about to start a titration with Effentora®, c) patients who agreed to particpate in the study and provided a signed Informed Consent form. Patients were excluded from the study if they filled any of the following conditions a) patients under legal guardianship, b) patinets unable or unwilling to complete the AE diary or the patient questionnaire, or patients who did not have a caregiver able to complete the AE diary for him/her, c) patients participating in a clinical trial at the time of study inclusion. Data were collected from patients and physicians and included physicians' and patients' demographics and reason for non-participation, medical history, aetiology of pain, opioid use and abuse, AEs, treatment effectiveness, performance status and satisfaction with educational brochure.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Sigal Kaplan

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Teva
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)