Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy Study 2

March 29, 2019 updated by: Procter and Gamble

Retention of an Orally Administered Investigational Device vs Commerical Device in the Oral Cavity and Oropharynx of Healthy Human Male Volunteers

Single usage, open label study in up to 40 adult healthy males. Eligible subjects will receive a single usage of the investigational or commercial device. Retention of the radiolabeled device will be monitored using gamma scintigraphy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Walter J Doll, PhD, RPh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Device: Polymer based lubricating liquid
5 mls of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane
Active Comparator: 2
Device: Moi-Stir
2 sprays (0.35 mL) of the radiolabeled commercial device. A blend of Water, sorbitol, carboxymethylcellulose, sodium, methylparaben, propylparaben, potassium chloride, dibasic sodium phosphate, calcium chloride, magnesium chloride, sodium chloride, flavor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the curve for volume of investigational device retained in the oral cavity.
Time Frame: 60 minutes
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Procter and Gamble

Investigators

  • Principal Investigator: Walter J Doll, PhD, RPh, Scintipharma, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

October 24, 2008

First Submitted That Met QC Criteria

October 24, 2008

First Posted (Estimate)

October 27, 2008

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

March 29, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2008068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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