Evaluate Retention of an Orally Administered Device Using... | NCT00754091

Studies
Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy

NCT00754091

Sponsor

Procter and Gamble

Status

Completed

Last Update Posted

Mar 26, 2019Actual

Enrollment

16Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

Polymer based lubricating liquid

Countries

United States

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

Mar 2019

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

Jun 2008

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jul 9, 2008

First Submission Date that Met QC Criteria

Sep 15, 2008

First Posted Date

Sep 17, 2008Estimated

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

Mar 22, 2019

Last Update Posted Date

Mar 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Single usage, open label study in 16 adult healthy males. Eligible subjects will receive a single usage of the investigational device. Retention of the radiolabeled device will be monitored using gamma scintigraphy.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Device: Polymer based lubricating liquid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polymer based lubricating liquid	Device	three sprays of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the curve for the percent of the mucoadhesive liquid retained in the oropharynx		one hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Refrain from nasal, throat, or lung inhalants and exercise for 24 hour prior to the test
Are able to tolerate the procedure and
Be generally healthy

Exclusion Criteria:

Have history of allergy or hypersensitivity to the study ingredients
Major diseases
Taking medication regularly
Radiation exposure recently

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Walter J Doll, PhD, RPh	Scintipharma, Inc	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Walter J Doll, PhD, RPh		Lexington	Kentucky	40503	United States