Effects of Mucoprotective Product on Xerostomia | NCT01316393

Studies
Effects of Mucoprotective Product on Xerostomia

NCT01316393

Sponsor

Camurus AB

Status

Completed

Last Update Posted

Nov 9, 2011Estimated

Enrollment

20Actual

Phase

Phase 4

Conditions

Xerostomia

Interventions

XER2020

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

May 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Mar 15, 2011

First Submission Date that Met QC Criteria

Mar 15, 2011

First Posted Date

Mar 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2011

Last Update Posted Date

Nov 9, 2011Estimated

Name	Class
Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
XER2020	Experimental	mucoprotective product	Other: XER2020
Saliva Natura	Active Comparator	salivary substitute	Other: XER2020
XER2020 placebo	Placebo Comparator		Other: XER2020

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XER2020	Other	mucoprotective product	Saliva Natura XER2020 XER2020 placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OHIP questionaire health impact profile	Effect on oral health quality will be assessed after each treatment period	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Prosthetic Dentistry, Malmö University		Malmö		SE-21421	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D014987	Xerostomia

Ancestor Terms

ID	Term
D012466	Salivary Gland Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided