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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

August 26, 2011
April 29, 2014
April 2011
April 2013   (final data collection date for primary outcome measure)
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 ]
assess the cost-effectiveness ratio is the number of days with severe mucositis won. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01426295 on ClinicalTrials.gov Archive Site
  • 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 ]
  • The number of days without medication morphine won [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Aggregate saving medicines prescribed Supportive [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • - The incidence and severity of mucositis [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • The intensity and duration of pain assessed with a visual analogue scale, [ Time Frame: 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 incidence and duration of febrile neutropenia [ Time Frame: 28 jours ] [ 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 and duration of total parenteral nutrition, [ Time Frame: 28 jours ] [ Designated as safety issue: No ]
  • - The duration of Release aplasia (ANC> 500/mm3), [ Time Frame: 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 ]
Not Provided
Not Provided
 
Pharmaco-economic Study of a New Medical Device Performed ​​From the Perspective of the Hospital
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Hematologic Disease
  • 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 ®.

  • Experimental: Caphosol
    Intervention: Device: Caphosol
  • Active Comparator: Référence
    •Bicarbonate de sodium à 1.4% Biosedra Versylène® or PAROEX® :
    Intervention: Drug: Bicarbonate de sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
April 2014
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01426295
BRD 10/06-C
Yes
Nantes University Hospital
Nantes University Hospital
EUSA Pharma (US), Inc.
Principal Investigator: Thomas Gastinne, M D Nantes University Hospital
Nantes University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP