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Effects of Mucoprotective Product on Xerostomia

This study has been completed.
Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden
Information provided by (Responsible Party):
Camurus AB Identifier:
First received: March 15, 2011
Last updated: November 8, 2011
Last verified: November 2011
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
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

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 ]
    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


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01316393

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

Responsible Party: Camurus AB 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

Keywords provided by Camurus AB:
xerostomia, saliva, mucoprotection, oral health

Additional relevant MeSH terms:
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases processed this record on September 21, 2017