ITMO Santé Publique
ITMO Santé Publique
Date de modification : 01/01/2019 | Version : 1 | ID : 146
| Général | |
| Identification | |
| Nom détaillé | Observational study of the real-world usage, efficacy and safety of rosiglitazone in Type 2 diabetics |
| Sigle ou acronyme | AVANCE |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CCTIRS : 05.309 |
| Thématiques générales | |
| Domaine médical |
Endocrinology and metabolism |
| Mots-clés | pharmaco-epidémiologY, rosiglitazone |
| Responsable(s) scientifique(s) | |
| Nom du responsable | Leclerc-Zwirn |
| Prénom | Christel |
| Téléphone | +33 (0)1 39 17 86 96 |
| christel.c.leclerc-zwirn@gsk.com | |
| Laboratoire | Laboratoire GSK |
| Collaborations | |
| Financements | |
| Financements |
Private |
| Précisions | Laboratoire GSK |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | Laboratoire GSK |
| Statut de l’organisation |
Secteur Privé |
| Contact(s) supplémentaire(s) | |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Base de données issues d'enquêtes, précisions |
Longitudinal study (except cohorts) |
| Origine du recrutement des participants |
A selection of health care professionals |
| Critère de sélection des participants |
Medication(s) taken |
| Le recrutement dans la base de données s'effectue dans le cadre d'une étude interventionnelle |
No |
| Informations complémentaires concernant la constitution de l'échantillon |
Physicians are to be randomly selected from the CEGEDIM data base. To take stock of refusals, a pool will be constituted containing three times as many specialists and general practitioners as will eventually be required. Every physician in each pool (specialists and general practitioners) will be randomly attributed a number. Lists will then be compiled in ascending order, using this random number. Physicians will then be successively solicited in the order of appearance of their names on the list until the required number of general practitioners or specialists has been attained. The planned inclusion period is nine months. This duration could nevertheless be extended if there are recruitment problems, or curtailed if enough patients have been recruited. During this period, all the Investigating Physicians will be asked to include all patients they see (in consultations or home visits) who start or have recently started (within the previous 30 days) a course of rosiglitazone treatment and who have agreed to take part in the Study, until a maximum number of patients has been reached, namely 4 for the general practitioners and 5 for the specialists. Participating physicians will also be asked to fill out a non-inclusion record for every patient who was in theory eligible but was not included (with the reason for non-inclusion). |
| Objectif de la base de données | |
| Objectif principal | To describe the profiles of patients being treated by general practitioners and specialists, compatibility of practice with the SPC, patient compliance, and the safety and efficacy of rosiglitazone in "real-world" conditions of use. |
| Critères d'inclusion |
- Type 2 diabetic spontaneously consulting (i.e. independently of the study); - Patient who is starting or has recently started (within a month) a course of treatment with Avandia® or Avandamet®; - Patient who has given his/her consent to participate. |
| Type de population | |
| 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 concernée |
Sick population |
| Sexe |
Male Woman |
| Champ géographique |
National |
| Détail du champ géographique | France |
| Collecte | |
| Dates | |
| Année du premier recueil | 2006 |
| Année du dernier recueil | 2009 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
[1000-10 000[ individuals |
| Détail du nombre d'individus | 1120 |
| Données | |
| Activité de la base |
Data collection completed |
| Type de données recueillies |
Clinical data Declarative data |
| Données cliniques, précisions |
Direct physical measures Medical registration |
| Données déclaratives, précisions |
Paper self-questionnaire Face to face interview |
| Existence d’une biothèque |
No |
| Paramètres de santé étudiés |
Health event/morbidity Health event/mortality Health care consumption and services |
| Consommation de soins, précisions |
Medicines consumption |
| Modalités | |
| Mode de recueil des données | CRF and self administrated questionnaire |
| Suivi des participants |
Yes |
| Détail du suivi | Data will be collected at 5 stages : At inclusion After about 6 months (Follow-Up Visit 1):Up Visit 3) After about 12 months (Follow-Up Visit 2) After about 18 months (Follow-Up Visit 3) After about 24 months (End-of-Study Visit) |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Accès | |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) | Publication in congress |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
Access on specific project only |
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