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

NCT ID: NCT01426295

Last Updated: 2016-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-04-30

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 in adult patients with auto or allograft packaging without ICT versus mouthwashes standard bicarbonates with an antiseptic (strategy B).

Conditions

Hematologic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Caphosol

Group Type: EXPERIMENTAL

Caphosol

Intervention Type: 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.

Référence

•Bicarbonate de sodium à 1.4% Biosedra Versylène® or PAROEX® :

Group Type: ACTIVE_COMPARATOR

Bicarbonate de sodium

Intervention Type: 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 ®.

Interventions

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.

Intervention Type: DEVICE

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 ®.

Intervention Type: DRUG

Eligibility Criteria

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 busulfan IV
• Patients belong to a schema of social security, having signed the written informed consent.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Gastinne, M D

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Nantes Universty Hospital

Nantes, , France

Countries

France

Other Identifiers

BRD/10/06-C

Identifier Type: -

Identifier Source: org_study_id