Skip to main content
OpenTrials
Completed

NCT Number: NCT00780286

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subjects

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Walter J Doll, PhD, RPh

Lexington, Kentucky, 40503, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polymer based lubricating liquid

Device

5 mls of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane

Moi-Stir

Device

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.

Primary outcomes

  1. Area under the curve for volume of investigational device retained in the oral cavity.

    Time frame: 60 minutes

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 27, 2008
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.