Status:
COMPLETED
Pharmaco-economic Study of a New Medical Device Performed From the Perspective of the Hospital
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Jazz Pharmaceuticals
Conditions:
Hematologic Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine whether the use of mouthwashes Caphosol ™ in addition to standard oral care (strategy A) is cost-effective in the prevention and treatment of severe mucositis ...
Eligibility Criteria
Inclusion
- 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 busulfan IV
- Patients belong to a schema of social security, having signed the written informed consent.
Exclusion
- patients:
- To receive or have received KGF
- With previous history of RT with the exception of patients who received spinal analgesic therapy in the treatment of myeloma
- Unable or unwilling to complete the self assessment questionnaire
- With previous history of allergy to any component of the products under consideration
- Minor
- Adults under guardianship
- Pregnant women
- Patients who have not signed the consent form
- Creation of mouthwash out of the study
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01426295
Start Date
April 1 2011
End Date
April 1 2014
Last Update
May 3 2016
Active Locations (1)
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1
Nantes Universty Hospital
Nantes, France, 44200