Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy Study 2
Retention of an Orally Administered Investigational Device vs Commerical Device in the Oral Cavity and Oropharynx of Healthy Human Male Volunteers
1 other identifier
interventional
32
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 24, 2008
CompletedFirst Posted
Study publicly available on registry
October 27, 2008
CompletedApril 2, 2019
March 1, 2019
Same day
October 24, 2008
March 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the curve for volume of investigational device retained in the oral cavity.
60 minutes
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
5 mls of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Have history of allergy or hypersensitivity to the study ingredients
- Major diseases
- Taking medication regularly
- Radiation exposure recently
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Walter J Doll, PhD, RPh
Lexington, Kentucky, 40503, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Walter J Doll, PhD, RPh
Scintipharma, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2008
First Posted
October 27, 2008
Study Start
October 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
April 2, 2019
Record last verified: 2019-03