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Trial of Topical Verapamil in Chronic Rhinosinusitis With Nasal Polyps

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ClinicalTrials.gov Identifier: NCT03102190
Recruitment Status : Terminated (Phase II funding not available)
First Posted : April 5, 2017
Results First Posted : June 21, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Benjamin Bleier, Massachusetts Eye and Ear Infirmary

Study Type Interventional
Study Design Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Sinusitis
Nasal Polyps
Intervention Drug: Verapamil Hydrochloride Intranasal
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase Ib
Hide Arm/Group Description Verapamil Hydrochloride Intranasal: Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Phase Ib
Hide Arm/Group Description Verapamil Hydrochloride Intranasal: Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
1
  16.7%
Male
5
  83.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  16.7%
White
5
  83.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicity
Hide Description Dose Limiting Toxicity will be defined as a development of 2nd or 3rd degree heart block as measured by an EKG. (Phase Ib primary outcome)
Time Frame 1-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase Ib
Hide Arm/Group Description:
Verapamil Hydrochloride Intranasal: Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase Ib
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis The analysis of the safety endpoints will be presented with means and standard deviations of their occurrence within the study population. The safety of the drug will be determined by analyzing the rate of adverse events in both phases of the trial. An occurrence of 10% within the study population will be considered significant.
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase Ib
Hide Arm/Group Description Verapamil Hydrochloride Intranasal: Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
All-Cause Mortality
Phase Ib
Affected / at Risk (%)
Total   0/6 (0.00%)    
Hide Serious Adverse Events
Phase Ib
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase Ib
Affected / at Risk (%) # Events
Total   2/6 (33.33%)    
Cardiac disorders   
Low heart rate   1/6 (16.67%)  3
General disorders   
Headache *  1/6 (16.67%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Project Manager, Clinical Trials
Organization: Massachusetts Eye and Ear Infirmary
Phone: 617-573-6981
EMail: elizabeth_grimm@meei.harvard.edu
Publications:
Layout table for additonal information
Responsible Party: Benjamin Bleier, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT03102190    
Other Study ID Numbers: 17-002H
First Submitted: February 14, 2017
First Posted: April 5, 2017
Results First Submitted: March 26, 2019
Results First Posted: June 21, 2019
Last Update Posted: July 23, 2019