PIUS - Patient reported Instanyl® Use Study
Head :
Moore Nicholas, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Blin Patrick, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Blin Patrick, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Last update : 10/26/2017 | Version : 1 | ID : 2943
| General | |
| Identification | |
| Detailed name | Patient reported Instanyl® Use Study |
| Sign or acronym | PIUS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTIRS 11.168, CNIL 911153 |
| General Aspects | |
| Medical area |
Cancer research |
| Health determinants |
Addictions Medicine |
| Keywords | opioid, breakthrough pain, misuse, abuse, risk management plan, Instanyl®, fentanyl, cancer, Pharmacoepidemiology, Department of Pharmacology, Bordeaux |
| Scientific investigator(s) (Contact) | |
| Name of the director | Moore |
| Surname | Nicholas |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33 (0)5 57 57 46 75 |
| nicholas.moore@pharmaco.u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Name of the director | Blin |
| Surname | Patrick |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33 (0)5 57 57 46 75 |
| patrick.blin@pharmaco.u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Nycomed (unconditional support) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | The study is conducted among patients who received a dispensation of Instanyl® in a non-hospital pharmacy. These pharmacies are identified by the wholesaler who distributes the drug along with study information sheet (pharmacist and patient) and study questionnaire. |
| Database objective | |
| Main objective | The objective is to evaluate the misuse, diversion and abuse of Instanyl® reported by patients in real life. Data collected in the study on off-label prescriptions will complement the study data in five north-European countries (LINUS study, record Linkage Instanyl Use Study). |
| Inclusion criteria | Patient who received a dispensation of Instanyl® from non-hospital pharmacies |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Non-hospital pharmacies in metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2011 |
| Date of last collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 600 patients inclus - 600 patients included |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Declarative data |
| Declarative data (detail) |
Paper self-questionnaire |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | Patients agreeing to participate completed a strictly anonymous questionnaire. |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | A confidential study report was delivered to the pharmaceutical company. Ownership of study data is the subject of an agreement between the University of Bordeaux Segalen and the pharmaceutical company. Terms for third-party access to the database are to be defined. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
