Pharmaco-economic Study of a New Medical Device Performed From the Perspective of the Hospital

PHASE2CompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2014

Conditions
Hematologic Disease
Interventions
DEVICE

Caphosol

"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."

DRUG

Bicarbonate de sodium

"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 ®."

Trial Locations (1)

44200

Nantes Universty Hospital, Nantes

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Jazz Pharmaceuticals

INDUSTRY

lead

Nantes University Hospital

OTHER