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

NCT01426295 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2016-05-03

No results posted yet for this study

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

Interventions

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 ®.

Sponsors & Collaborators

Principal Investigators

  • Thomas Gastinne, M D · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-04-30
Completion
2014-04-30

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01426295 on ClinicalTrials.gov