NCT01316393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

3 months

First QC Date

March 15, 2011

Last Update Submit

November 8, 2011

Conditions

Xerostomia

Keywords

xerostomia, saliva, mucoprotection, oral health

Outcome Measures

Primary Outcomes (1)

  • OHIP questionaire health impact profile

    Effect on oral health quality will be assessed after each treatment period

    7 days

Study Arms (3)

XER2020

EXPERIMENTAL

mucoprotective product

Other: XER2020

Saliva Natura

ACTIVE COMPARATOR

salivary substitute

Other: XER2020

XER2020 placebo

PLACEBO COMPARATOR
Other: XER2020

Interventions

XER2020OTHER

mucoprotective product

Saliva NaturaXER2020XER2020 placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must be at least 18 years of age.
  • The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of head and neck cancer
  • The patient must understand and consent in writing to the procedure.

You may not qualify if:

  • Do not meet the criterion for "dry mouth" regarding saliva secretion threshold values.
  • 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
  • Patients who are unable or unwilling to cooperate with study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Prosthetic Dentistry, Malmö University

Malmo, SE-21421, Sweden

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2011

First Posted

March 16, 2011

Study Start

February 1, 2011

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations

SE(1)