NCT00754091

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 17, 2008

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

Same day

First QC Date

July 9, 2008

Last Update Submit

March 22, 2019

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Area under the curve for the percent of the mucoadhesive liquid retained in the oropharynx

    one hour

Study Arms (1)

1

EXPERIMENTAL
Device: Polymer based lubricating liquid

Interventions

Polymer based lubricating liquidDEVICE

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

1

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

Study Officials

  • Walter J Doll, PhD, RPh

    Scintipharma, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2008

First Posted

September 17, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

US(1)