XerostomiaPhase 4NCT01316393
Effects of Mucoprotective Product on Xerostomia
A Phase 4 study testing XER2020 in people with Xerostomia, run by Camurus AB at 1 site in Sweden.
Trial summary
In the present study with a randomized, cross-over, blind, placebo controlled design, the effects of a salivary substitute product and a new mucoprotective product with similar mechanisms of action but with different composition and characteristics will be evaluated in cancer patients suffering from xerostomia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Xerostomia
- What is being tested?
- XER2020
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2011to Jun 2011
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be at least 18 years of age.
- The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of head and neck cancer
- The patient must understand and consent in writing to the procedure.
Who cannot join
- Do not meet the criterion for "dry mouth" regarding saliva secretion threshold values.
- Known allergy to ingredients in the products to be used in the trial and/or allergy to soy, peanuts, citrus fruit,Yerba Santa or methyl parabene
- Patients who are unable or unwilling to cooperate with study procedures.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Prosthetic Dentistry, Malmö University
Malmö, SE-21421
About this study
Official title: Clinical Evaluation of a Salivary Substitute and a Mucoprotective Product on Xerostomia in Head-and-neck Cancer Patients
In the present study with a randomized, cross-over, blind, placebo controlled design, the effects of a salivary substitute product and a new mucoprotective product with similar mechanisms of action but with different composition and characteristics will be evaluated in cancer patients suffering from xerostomia.
- Conditions
- Xerostomia
- Being tested
- XER2020
- Keywords
- xerostomia, saliva, mucoprotection, oral health
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XER2020Other
mucoprotective product
| Study group | Role | What they receive |
|---|---|---|
| XER2020 | Experimental | mucoprotective product Receives: Other: XER2020 |
| Saliva Natura | Active comparator | salivary substitute Receives: Other: XER2020 |
| XER2020 placebo | Placebo comparator | Not described Receives: Other: XER2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
OHIP questionaire health impact profile
Effect on oral health quality will be assessed after each treatment period
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camurus AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316393
- Sponsor's protocol ID
- HS-10-404
- Status last verified
- Nov 2011
- First submitted
- 15 Mar 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Salivary Substitute and a Mucoprotective Product on Xerostomia in Head-and-neck Cancer Patients
- ClinicalTrials.gov ID
- NCT01316393
- Acronym / sponsor ID
- HS-10-404
- Conditions
- Xerostomia
- Keywords
- xerostomia, saliva, mucoprotection, oral health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Camurus ABIndustry (pharma, biotech, devices)
- Collaborators
- Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Mar 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.
In the present study with a randomized, cross-over, blind, placebo controlled design, the effects of a salivary substitute product and a new mucoprotective product with similar mechanisms of action but with different composition and characteristics will be evaluated in cancer patients suffering from xerostomia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| XER2020 | Experimental | Other: XER2020mucoprotective product |
| Saliva Natura | Active comparator | Other: XER2020salivary substitute |
| XER2020 placebo | Placebo comparator | Other: XER2020 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient must be at least 18 years of age.
- The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of head and neck cancer
- The patient must understand and consent in writing to the procedure.
Key exclusion criteria (3 listed)
- Do not meet the criterion for "dry mouth" regarding saliva secretion threshold values.
- Known allergy to ingredients in the products to be used in the trial and/or allergy to soy, peanuts, citrus fruit,Yerba Santa or methyl parabene
- Patients who are unable or unwilling to cooperate with study procedures.
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 |
|---|---|---|
| XER2020mucoprotective product | Other | Saliva Natura, XER2020, XER2020 placebo |
Primary outcome
OHIP questionaire health impact profile
Time frame: 7 days
Effect on oral health quality will be assessed after each treatment period
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 9 Nov 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing XER2020 in people with Xerostomia, run by Camurus AB at 1 site in Sweden.
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 3 inclusion and 3 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 9 Nov 2011. 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 Sweden. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
OHIP questionaire health impact profile (time frame: 7 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 9 Nov 2011.