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Effects of Mucoprotective Product on Xerostomia

NCT ID: NCT01316393

Last Updated: 2011-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Xerostomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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XER2020

mucoprotective product

Group Type EXPERIMENTAL

XER2020

Intervention Type OTHER

mucoprotective product

Saliva Natura

salivary substitute

Group Type ACTIVE_COMPARATOR

XER2020

Intervention Type OTHER

mucoprotective product

XER2020 placebo

Group Type PLACEBO_COMPARATOR

XER2020

Intervention Type OTHER

mucoprotective product

Interventions

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XER2020

mucoprotective product

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden

UNKNOWN

Sponsor Role collaborator

Camurus AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Prosthetic Dentistry, Malmö University

Malmo, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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HS-10-404

Identifier Type: -

Identifier Source: org_study_id

NCT01288118

Identifier Type: -

Identifier Source: nct_alias