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Effects of Mucoprotective Product on Xerostomia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01316393
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : November 9, 2011
Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden
Information provided by (Responsible Party):
Camurus AB

Brief 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.

Condition or disease Intervention/treatment Phase
Xerostomia Other: XER2020 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Clinical Evaluation of a Salivary Substitute and a Mucoprotective Product on Xerostomia in Head-and-neck Cancer Patients
Study Start Date : February 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. OHIP questionaire health impact profile [ Time Frame: 7 days ]
    Effect on oral health quality will be assessed after each treatment period

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01316393

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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

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Responsible Party: Camurus AB Identifier: NCT01316393     History of Changes
Obsolete Identifiers: NCT01288118
Other Study ID Numbers: HS-10-404
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: November 9, 2011
Last Verified: November 2011
Keywords provided by Camurus AB:
xerostomia, saliva, mucoprotection, oral health
Additional relevant MeSH terms:
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Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases