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NCT01316393 Clinical Trial

Effects of Mucoprotective Product on Xerostomia

Xerostomia Clinical Trial

Official title:
Clinical Evaluation of a Salivary Substitute and a Mucoprotective Product on Xerostomia in Head-and-neck Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01316393
Other study ID # HS-10-404
Secondary ID
Status Completed
Phase Phase 4
First received March 15, 2011
Last updated November 8, 2011
Start date February 2011
Est. completion date June 2011

Study information
Verified date November 2011
Source Camurus AB
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Product Agency
Study type Interventional

Clinical 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.

Other known NCT identifiers
  • NCT01288118

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

1. The patient must be at least 18 years of age.

2. The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of head and neck cancer

3. The patient must understand and consent in writing to the procedure.

Exclusion Criteria:

1. Do not meet the criterion for "dry mouth" regarding saliva secretion threshold values.

2. 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

3. Patients who are unable or unwilling to cooperate with study procedures.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Other:
• XER2020
mucoprotective product

Locations
Country Name City State
Sweden Department of Prosthetic Dentistry, Malmö University Malmö

Sponsors (2)
Lead Sponsor Collaborator
Camurus AB Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary OHIP questionaire health impact profile Effect on oral health quality will be assessed after each treatment period 7 days Yes
See also
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Completed NCT03611283 - Topical Management of Xerostomia With Dry Mouth Products N/A
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