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Treatment of Early Nasal Polyposis With Topical Triamcinolone

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ClinicalTrials.gov Identifier: NCT01222871
Recruitment Status : Terminated (not enough particpants)
First Posted : October 18, 2010
Results First Posted : June 28, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Catalano, Steward St. Elizabeth's Medical Center of Boston, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Nasal Polyps
Interventions Drug: Triamcinolone
Drug: Saline soaked sponge
Enrollment 1
Recruitment Details  
Pre-assignment Details One subject enrolled but study was terminated and subject did not start the study.
Arm/Group Title Triamcinolone Control
Hide Arm/Group Description Nasopore Triamcinolone soaked sponge Saline soaked sponge
Period Title: Overall Study
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title Triamcinolone Control Total
Hide Arm/Group Description Nasopore Triamcinolone soaked sponge Saline Soaked sponge Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
0
Age, Categorical   [1] 
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
[1]
Measure Description: No participant started because study was terminated.
Sex: Female, Male   [1] 
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
[1]
Measure Description: No participant started because study was terminated.
1.Primary Outcome
Title Nasal Endoscopic Exam Findings .
Hide Description nasal endoscopic exam findings at 2 weeks, 6 weeks and 12 weeks were not collected from any participant.
Time Frame 2 weeks, 6 weeks, 12 weeks were not collected from any participant.
Hide Outcome Measure Data
Hide Analysis Population Description
No participant started because study was terminated.
Arm/Group Title Triamcinolone Control
Hide Arm/Group Description:
Nasopore Triamcinolone soaked sponge
Saline soaked sponge
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame no data collected, Study terminated.
Adverse Event Reporting Description No data collected, study terminated.
 
Arm/Group Title Triamcinolone Saline Soaked Sponge Control
Hide Arm/Group Description Nasopore Triamcinolone soaked sponge Nasopore saline soaked sponge Saline soaked sponge
All-Cause Mortality
Triamcinolone Saline Soaked Sponge Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Triamcinolone Saline Soaked Sponge Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Triamcinolone Saline Soaked Sponge Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Peter catalano
Organization: SEMC
Phone: 1-617-789-5004
EMail: peter.catalano@steward.org
Layout table for additonal information
Responsible Party: Peter Catalano, Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier: NCT01222871     History of Changes
Other Study ID Numbers: 00540
First Submitted: October 14, 2010
First Posted: October 18, 2010
Results First Submitted: December 12, 2014
Results First Posted: June 28, 2018
Last Update Posted: June 28, 2018