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Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00754091
Recruitment Status : Completed
First Posted : September 17, 2008
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Device: Polymer based lubricating liquid Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Retention of an Orally Administered Investigational Device in the Oropharynx of Healthy Human Male Volunteers
Study Start Date : June 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
Experimental: 1 Device: Polymer based lubricating liquid
three sprays of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane




Primary Outcome Measures :
  1. Area under the curve for the percent of the mucoadhesive liquid retained in the oropharynx [ Time Frame: one hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754091


Locations
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United States, Kentucky
Walter J Doll, PhD, RPh
Lexington, Kentucky, United States, 40503
Sponsors and Collaborators
Procter and Gamble
Investigators
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Principal Investigator: Walter J Doll, PhD, RPh Scintipharma, Inc
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Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00754091    
Other Study ID Numbers: 2008046
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No