Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01426295 | Pharmaco-economic Study of a New Medical Device Performed From the Perspective of the Hospital | PHASE2 | COMPLETED | 92 | — | — | Apr 1, 2011 | Apr 1, 2014 | May 3, 2016 | 1 | France |
| Arm | Type | Description |
|---|---|---|
| Caphosol | EXPERIMENTAL | - |
| Référence | ACTIVE_COMPARATOR | •Bicarbonate de sodium à 1.4% Biosedra Versylène® or PAROEX® : |
| Name | Type | Description |
|---|---|---|
| Caphosol | DEVICE | The Caphosol ™ is a recently launched medical in France (2009). (source: laboratory EUSA Pharma ®) The product is an aqueous solution for mouthwash that comes in the form of a hyper-saturated mixture of calcium phosphate at neutral pH to reconstitute immediately before use. Each patient randomized to the treatment arms in the study will receive daily at least 4 (maximum 10) mouthwash Caphosol ™. The treatments are to begin preventive J1 to chemotherapy and continued until out of aplasia (ANC\> 500/mm3), and / or mucositis grade 0. |
| Bicarbonate de sodium | DRUG | Treatment of the early start on the day of conditioning and stop when the ANC\> 500/mm3 and / or mucositis grade zero, provisional date of bone exceeded. Versylène: Method of administration: gargle made with a minute from 15 to 30 mL, 2-5 times a day, alternating with PAROEX ®. |
Inclusion Criteria: * Patients \> 18 years Patient receiving: * Conditioning of autologous bone marrow transplantation by high dose melphalan (HD) as part of the management of myeloma or BEAM in lymphoma. * A conditioning allogeneic bone marrow transplantation with reduced or intermediate busulfa...