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Effects of Mucoprotective Product on Xerostomia

This study has been completed.
Sponsor:
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
  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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Xerostomia
Mouth Diseases
Salivary Gland Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 25, 2014