Hematologic DiseasePhase 2CaphosolNCT01426295
Pharmaco-economic Study of a New Medical Device Performed From the Perspective of the Hospital
A Phase 2 study testing Caphosol and Bicarbonate de sodium in people with Hematologic Disease, run by Nantes University Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Disease
- What is being tested?
- Caphosol and Bicarbonate de sodium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Adults under guardianship
- Pregnant women
- Patients who have not signed the consent form
- Creation of mouthwash out of the study
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Caphosol, Bicarbonate de sodium
- Keywords
- hematologic disease candidates for autologous or allogeneic bone marrow
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaphosolDevice
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.
Bicarbonate de sodiumDrug
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 ®.
| Study group | Role | What they receive |
|---|---|---|
| Caphosol | Experimental | Not described Receives: Device: Caphosol |
| Référence | Active comparator | •Bicarbonate de sodium à 1.4% Biosedra Versylène® or PAROEX® : Receives: Drug: Bicarbonate de sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the cost-effectiveness ratio is the number of days with severe mucositis won.
Measured: up to 28 days
Secondary outcomes (12)
The number of days without medication morphine won
Measured: up to 28 days
Aggregate saving medicines prescribed Supportive
Measured: up to 28 days
The incidence of mucositis
Measured: up to 28 days
The intensity of pain assessed with a visual analogue scale
Measured: up to 28 days
The cumulative dose of morphine administered and the number of days of treatment,
Measured: 28 days
The duration of febrile neutropenia
Measured: up to 28 days
- The incidence and duration of treatment of anti-infective and antifungal
Measured: 28 jours
The incidence of total parenteral nutrition
Measured: up to 28 days
- The duration of Release aplasia (ANC> 500/mm3),
Measured: up to 28 days
The duration of the hospitalization
Measured: participants will be followed for the duration of hospital stay, an expected average of 28 days
The severity of mucositis
Measured: up to 28 days
The duration of pain assessed with a visual analogue scale,
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Thomas Gastinne, M D, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426295
- Sponsor's protocol ID
- BRD/10/06-C
- Acronym
- Caphosol
- Status last verified
- Apr 2016
- First submitted
- 26 Aug 2011
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01426295
- Acronym / sponsor ID
- Caphosol / BRD/10/06-C
- Conditions
- Hematologic Disease
- Keywords
- hematologic disease candidates for autologous or allogeneic bone marrow
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 31 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caphosol | Experimental | Device: Caphosol |
| Référence | Active comparator | Drug: Bicarbonate de sodium•Bicarbonate de sodium à 1.4% Biosedra Versylène® or PAROEX® : |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients > 18 years
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaphosolThe 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. | Device | Caphosol |
| Bicarbonate de sodiumTreatment 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 ®. | Drug | Référence |
Primary outcome
assess the cost-effectiveness ratio is the number of days with severe mucositis won.
Time frame: up to 28 days
12 secondary outcomes
The number of days without medication morphine won
Time frame: up to 28 days
Aggregate saving medicines prescribed Supportive
Time frame: up to 28 days
The incidence of mucositis
Time frame: up to 28 days
The intensity of pain assessed with a visual analogue scale
Time frame: up to 28 days
The cumulative dose of morphine administered and the number of days of treatment,
Time frame: 28 days
The duration of febrile neutropenia
Time frame: up to 28 days
- The incidence and duration of treatment of anti-infective and antifungal
Time frame: 28 jours
The incidence of total parenteral nutrition
Time frame: up to 28 days
- The duration of Release aplasia (ANC> 500/mm3),
Time frame: up to 28 days
The duration of the hospitalization
Time frame: participants will be followed for the duration of hospital stay, an expected average of 28 days
The severity of mucositis
Time frame: up to 28 days
The duration of pain assessed with a visual analogue scale,
Time frame: up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Gastinne, M D principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Caphosol and Bicarbonate de sodium in people with Hematologic Disease, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the cost-effectiveness ratio is the number of days with severe mucositis won. (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.