E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoarthritis. The medical condition investigated in the CL3-12911-018 study was osteoarthritis. The applied CL3-12911-040 trial, CL3-12911-018 followup study, is thus performed in osteoarthritic patients. |
Osteoartrite. La condizione clinica studiata nello studio CL3-12911-018 era osteoartrite. Lo studio CL3-12911-040 oggetto della domanda, follow up dello studio CL3-12911-018 è quindi condotto su pazienti affetti da osteoartrite. |
|
E.1.1.1 | Medical condition in easily understood language |
Osteoarthritis |
Osteoartrite |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10028395 |
E.1.2 | Term | Musculoskeletal and connective tissue disorders |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10031161 |
E.1.2 | Term | Osteoarthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To collect data on knee joint replacement procedures or procedures practiced in the knee (arthroscopy, osteotomy or other) over 5 years in patients with knee osteoarthritis having participated in the CL3-12911- 018 study and having received at least one year (365 days) of CL3- 12911-018 study treatment (Strontium Ranelate 1g/2g or placebo). |
Raccogliere dati su eventuali interventi chirurgici di sostituzione parziale o totale dell'articolazione del ginocchio e/o interventi di recupero (artroscopia, osteotomia od altro tipo di procedura) per un arco di tempo di 5 anni in pazienti che hanno già partecipato allo studio CL3-12911-018 avendo assunto almeno 365 giorni di trattamento (ranelato di stronzio 1 o 2 gr/die o placebo). |
|
E.2.2 | Secondary objectives of the trial |
Non applicabile |
Non applicabile |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients included in the CL3-12911-018 study and having received the CL3-12911-018 study treatment (Strontium Ranelate 1g/2g or placebo) for at least one year (at least 365 days of treatment during the CL3- 12911-018 study). |
Pazienti che hanno già partecipato allo studio CL3-12911-018 avendo assunto almeno 365 giorni di trattamento (ranelato di stronzio 1 o 2 gr/die o placebo). |
|
E.4 | Principal exclusion criteria |
Unlikely to cooperate in the study (such as patients suffering from dementia). Patients unable to provide the information requested by the study. Refusal to provide the study's informed consent. |
- Pazienti non collaborativi allo studio (per es.: pazienti affetti da demenza). Pazienti impossibilitati a fornire le informazioni richieste dallo studio. Pazienti che non firmano il consenso informato. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Knee joint replacement in the target knee (knee followed in the CL3-12911-018 study). - Knee surgery or other procedure (arthroscopy, osteotomy or other). |
- Interventi chirurgici di sostituzione dell’articolazione del ginocchio target (il ginocchio considerato nel corso dello studio CL3-12911-018). -Intervento chirurgico al ginocchio o interventi di recupero (artroscopia, osteotomia od altro tipo di procedura). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Each 12 months. |
Ogni 12 mesi. |
|
E.5.2 | Secondary end point(s) |
Non applicabile |
Non applicabile |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Non applicabile |
Non applicabile |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Follow-up study without treatment administration |
Studio di follow-up senza somministrazione di prodotto |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Studio di follow-up che non prevede la somministrazione di un prodotto |
Follow-up study without treatment administration |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 0 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 71 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
Russian Federation |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last Visit Last Participant as stated in the protocol. |
Ultima visita dell'ultimo paziente come descritto nel protocollo. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 64 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 67 |
E.8.9.2 | In all countries concerned by the trial days | 0 |