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

NCT01426295 | Completed Phase 2 DMC

• 1 other identifier: BRD/10/06-C
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Keywords

hematologic disease candidates for autologous or allogeneic bone marrow

Outcome Measures

Primary Outcomes (1)

• assess the cost-effectiveness ratio is the number of days with severe mucositis won.

  up to 28 days

Secondary Outcomes (12)

• The number of days without medication morphine won

  up to 28 days

• Aggregate saving medicines prescribed Supportive

  up to 28 days

• The incidence of mucositis

  up to 28 days

• The intensity of pain assessed with a visual analogue scale

  up to 28 days

• The cumulative dose of morphine administered and the number of days of treatment,

  28 days

Study Arms (2)

Caphosol

EXPERIMENTAL

Device: Caphosol

Référence

ACTIVE COMPARATOR

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

Drug: Bicarbonate de sodium

Interventions

Caphosol 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.

Caphosol

Bicarbonate de sodium 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 ®.

Référence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Jazz Pharmaceuticals: collaborator

Study Sites (1)

Nantes Universty Hospital

Nantes, 44200, France

Location

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Thomas Gastinne, M D

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 31, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2014
• Last Updated: May 3, 2016

Record last verified: 2016-04

Locations

FR (1)