Salivary Catecholamines in Aphthous Stomatitis (Canker So... | NCT00556686

Studies
Salivary Catecholamines in Aphthous Stomatitis (Canker Sores)

NCT00556686

Sponsor

University of California, Davis

Status

Withdrawn

Last Update Posted

Apr 22, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Canker Sore

Interventions

Not provided

Countries

Not provided

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

Apr 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

We are currently modifying the study

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Nov 8, 2007

First Submission Date that Met QC Criteria

Nov 8, 2007

First Posted Date

Nov 12, 2007Estimated

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

Apr 20, 2015

Last Update Posted Date

Apr 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to examine how compounds produced in patients with canker sores affect wound healing.

Detailed Description

The purpose of this study is to determine if salivary catecholamines are elevated in patients with the disease aphthous stomatitis. The results of this study will be combined with those performed in collaboration with a co-Investigator to understand the effects of catecholamines on mucosal wound healing and oral epithelial cell migration.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Individuals with a history of canker sores.
2		Individuals with no history of canker sores.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or older, both genders
History of recurrent aphthous ulcers with 4 or more episodes per year

Exclusion Criteria:

History of salivary gland disease including Sjogren's disease, parotitis, and sialolithiasis
History of benign or malignant salivary gland tumor
History of celiac disease, ulcerative colitis or Crohn's disease
Patients on medications that affect salivary flow such as anti-depressants and anti-cholinergic medications

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All subjects will be sampled from the community.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nasim Fazel, MD, DDS	University of California, Davis	Principal Investigator

Locations

Not provided

References Module

Citations

Not provided

ID	Term
D013280	Stomatitis
D009059	Mouth Diseases
D009057	Stomatognathic Diseases