Effects of Mucoprotective Product on Xerostomia
This study has been completed.
Sponsor:
Camurus AB
Collaborator:
Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden
Information provided by (Responsible Party):
Camurus AB
ClinicalTrials.gov Identifier:
NCT01316393
First received: March 15, 2011
Last updated: November 8, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Xerostomia |
Other: XER2020 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | Clinical Evaluation of a Salivary Substitute and a Mucoprotective Product on Xerostomia in Head-and-neck Cancer Patients |
Resource links provided by NLM:
Further study details as provided by Camurus AB:
Primary Outcome Measures:
- OHIP questionaire health impact profile [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]Effect on oral health quality will be assessed after each treatment period
| Enrollment: | 20 |
| Study Start Date: | February 2011 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: XER2020
mucoprotective product
|
Other: XER2020
mucoprotective product
|
|
Active Comparator: Saliva Natura
salivary substitute
|
Other: XER2020
mucoprotective product
|
| Placebo Comparator: XER2020 placebo |
Other: XER2020
mucoprotective product
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316393
Locations
| Sweden | |
| Department of Prosthetic Dentistry, Malmö University | |
| Malmö, Sweden, SE-21421 | |
Sponsors and Collaborators
Camurus AB
Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden
More Information
No publications provided
| Responsible Party: | Camurus AB |
| ClinicalTrials.gov Identifier: | NCT01316393 History of Changes |
| Obsolete Identifiers: | NCT01288118 |
| Other Study ID Numbers: | HS-10-404 |
| Study First Received: | March 15, 2011 |
| Last Updated: | November 8, 2011 |
| Health Authority: | Sweden: Medical Product Agency |
Keywords provided by Camurus AB:
|
xerostomia, saliva, mucoprotection, oral health |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Xerostomia Neoplasms by Site Neoplasms |
Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013