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

Hematologic Disease Clinical Trial

— Caphosol  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426295
• Other study ID #: BRD/10/06-C
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2011
• Last updated: May 2, 2016
• Start date: April 2011
• Est. completion date: April 2014

Study information

• Verified date: April 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hematologic Disease
• Hematologic Diseases

Intervention

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 ®.

Locations

Country	Name	City	State
France	Nantes Universty Hospital	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Jazz Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the cost-effectiveness ratio is the number of days with severe mucositis won.		up to 28 days	No
Secondary	The number of days without medication morphine won		up to 28 days	No
Secondary	Aggregate saving medicines prescribed Supportive		up to 28 days	No
Secondary	The incidence of mucositis		up to 28 days	No
Secondary	The intensity of pain assessed with a visual analogue scale		up to 28 days	No
Secondary	The cumulative dose of morphine administered and the number of days of treatment,		28 days	No
Secondary	The duration of febrile neutropenia		up to 28 days	No
Secondary	- The incidence and duration of treatment of anti-infective and antifungal		28 jours	No
Secondary	The incidence of total parenteral nutrition		up to 28 days	No
Secondary	- The duration of Release aplasia (ANC> 500/mm3),		up to 28 days	No
Secondary	The duration of the hospitalization		participants will be followed for the duration of hospital stay, an expected average of 28 days	No
Secondary	The severity of mucositis		up to 28 days	Yes
Secondary	The duration of pain assessed with a visual analogue scale,		up to 28 days	No