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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01426295
Recruitment Status : Completed
First Posted : August 31, 2011
Last Update Posted : May 3, 2016
Jazz Pharmaceuticals
Information provided by (Responsible Party):
Nantes University Hospital

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).

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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Caphosol 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.

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 ®.

Primary Outcome Measures :
  1. assess the cost-effectiveness ratio is the number of days with severe mucositis won. [ Time Frame: up to 28 days ]

Secondary Outcome Measures :
  1. The number of days without medication morphine won [ Time Frame: up to 28 days ]
  2. Aggregate saving medicines prescribed Supportive [ Time Frame: up to 28 days ]
  3. The incidence of mucositis [ Time Frame: up to 28 days ]
  4. The intensity of pain assessed with a visual analogue scale [ Time Frame: up to 28 days ]
  5. The cumulative dose of morphine administered and the number of days of treatment, [ Time Frame: 28 days ]
  6. The duration of febrile neutropenia [ Time Frame: up to 28 days ]
  7. - The incidence and duration of treatment of anti-infective and antifungal [ Time Frame: 28 jours ]
  8. The incidence of total parenteral nutrition [ Time Frame: up to 28 days ]
  9. - The duration of Release aplasia (ANC> 500/mm3), [ Time Frame: up to 28 days ]
  10. The duration of the hospitalization [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 28 days ]
  11. The severity of mucositis [ Time Frame: up to 28 days ]
  12. The duration of pain assessed with a visual analogue scale, [ Time Frame: up to 28 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01426295

Nantes Universty Hospital
Nantes, France, 44200
Sponsors and Collaborators
Nantes University Hospital
Jazz Pharmaceuticals
Principal Investigator: Thomas Gastinne, M D Nantes University Hospital

Responsible Party: Nantes University Hospital Identifier: NCT01426295     History of Changes
Other Study ID Numbers: BRD/10/06-C
First Posted: August 31, 2011    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: April 2016

Keywords provided by Nantes University Hospital:
hematologic disease candidates for autologous or allogeneic bone marrow

Additional relevant MeSH terms:
Hematologic Diseases