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

This study has been completed.
Sponsor:
Collaborator:
EUSA Pharma (US), Inc.
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01426295
First received: August 26, 2011
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Hematologic Disease
Device: Caphosol
Drug: Bicarbonate de sodium
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • assess the cost-effectiveness ratio is the number of days with severe mucositis won. [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of days without medication morphine won [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • Aggregate saving medicines prescribed Supportive [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • The incidence of mucositis [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • The intensity of pain assessed with a visual analogue scale [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • The cumulative dose of morphine administered and the number of days of treatment, [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • The duration of febrile neutropenia [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • - The incidence and duration of treatment of anti-infective and antifungal [ Time Frame: 28 jours ] [ Designated as safety issue: No ]
  • The incidence of total parenteral nutrition [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • - The duration of Release aplasia (ANC> 500/mm3), [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • The duration of the hospitalization [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 28 days ] [ Designated as safety issue: No ]
  • The severity of mucositis [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
  • The duration of pain assessed with a visual analogue scale, [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: April 2011
Study Completion Date: April 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 ®.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426295

Locations
France
Nantes Universty Hospital
Nantes, France, 44200
Sponsors and Collaborators
Nantes University Hospital
EUSA Pharma (US), Inc.
Investigators
Principal Investigator: Thomas Gastinne, M D Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01426295     History of Changes
Other Study ID Numbers: BRD 10/06-C
Study First Received: August 26, 2011
Last Updated: April 29, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Hematologic Diseases

ClinicalTrials.gov processed this record on August 18, 2014