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

NCT00780286 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-04-02

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Subjects

Interventions

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

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.

Sponsors & Collaborators

  • Procter and Gamble

    lead INDUSTRY

Principal Investigators

  • Walter J Doll, PhD, RPh · Scintipharma, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00780286 on ClinicalTrials.gov