ClinicalTrials.gov
ClinicalTrials.gov Menu

An Open-label Study to Identify Molecular Markers of Steroid Resistance (MERK2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01616160
Recruitment Status : Terminated (Inability to recruit additional subjects.)
First Posted : June 11, 2012
Results First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Massachusetts Eye and Ear Infirmary
Information provided by (Responsible Party):
Daniel Hamilos MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Nasal Polyps
Intervention: Drug: mometasone furoate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nasal Polyps Subjects

Intervention: Each subject will receive Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.

mometasone furoate: 2 sprays/nostril BID


Participant Flow:   Overall Study
    Nasal Polyps Subjects
STARTED   11 
COMPLETED   9 
NOT COMPLETED   2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nasal Polyps Subjects

Intervention: Each subject will receive Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.

mometasone furoate: 2 sprays/nostril BID


Baseline Measures
   Nasal Polyps Subjects 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      11 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  18.2% 
Male      9  81.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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   9.1% 
White      10  90.9% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   11 


  Outcome Measures

1.  Primary:   Change in Steroid Sensitivity in Vivo Symptom Scores - Trouble With Sense of Smell   [ Time Frame: Change between pre- and post-treatment symptom score after 4 weeks of treatment ]

2.  Primary:   Change in Steroid Sensitivity in Vivo Nasal Endoscopy Polyp Scores   [ Time Frame: Change between pre- and post-treatment symptom score after 4 weeks of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Daniel L. Hamilos, M.D.
Organization: Massachusetts General Hospital
phone: 617-726-5090
e-mail: dhamilos@partners.org



Responsible Party: Daniel Hamilos MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01616160     History of Changes
Other Study ID Numbers: 2012P000387
First Submitted: May 30, 2012
First Posted: June 11, 2012
Results First Submitted: March 20, 2018
Results First Posted: June 12, 2018
Last Update Posted: June 12, 2018