Pharmaco-economic Study of a New Medical Device Performed From the Perspective of the Hospital (Caphosol)
|ClinicalTrials.gov Identifier: NCT01426295|
Recruitment Status : Completed
First Posted : August 31, 2011
Last Update Posted : May 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Disease||Device: Caphosol Drug: Bicarbonate de sodium||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmaco-economic Cost-effective Prospective Randomized Trial Evaluating the Open Interest Caphosol ® Mouthwashes in the Prevention and Treatment of Severe Oral Mucositis in Patients Receiving High-dose Chemotherapy in Hematology|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2014|
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.
Active Comparator: Référence
•Bicarbonate de sodium à 1.4% Biosedra Versylène® or PAROEX® :
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 ®.
- assess the cost-effectiveness ratio is the number of days with severe mucositis won. [ Time Frame: up to 28 days ]
- The number of days without medication morphine won [ Time Frame: up to 28 days ]
- Aggregate saving medicines prescribed Supportive [ Time Frame: up to 28 days ]
- The incidence of mucositis [ Time Frame: up to 28 days ]
- The intensity of pain assessed with a visual analogue scale [ Time Frame: up to 28 days ]
- The cumulative dose of morphine administered and the number of days of treatment, [ Time Frame: 28 days ]
- The duration of febrile neutropenia [ Time Frame: up to 28 days ]
- - The incidence and duration of treatment of anti-infective and antifungal [ Time Frame: 28 jours ]
- The incidence of total parenteral nutrition [ Time Frame: up to 28 days ]
- - The duration of Release aplasia (ANC> 500/mm3), [ Time Frame: up to 28 days ]
- The duration of the hospitalization [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 28 days ]
- The severity of mucositis [ Time Frame: up to 28 days ]
- The duration of pain assessed with a visual analogue scale, [ Time Frame: up to 28 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426295
|Nantes Universty Hospital|
|Nantes, France, 44200|
|Principal Investigator:||Thomas Gastinne, M D||Nantes University Hospital|