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DFN-02 Open Label Safety Study in Patients With Acute Migraine

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: NCT02279082
Recruitment Status : Completed
First Posted : October 30, 2014
Results First Posted : August 28, 2017
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Migraine
Intervention Drug: DFN-02
Enrollment 167
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DFN-02
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Active DFN-02 (Nasal Sumatriptan 10mg)

DFN-02: Active Experimental Drug

Period Title: Overall Study
Started 167 [1]
Completed 134
Not Completed 33
[1]
Intentions were to have 173 participants, but only 167 participants received study drug.
Arm/Group Title DFN-02 (Single Arm, Open Label)
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Active DFN-02

DFN-02: Active Experimental Drug

Overall Number of Baseline Participants 167
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants
<=18 years
0
   0.0%
Between 18 and 65 years
167
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants
Female
136
  81.4%
Male
31
  18.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   1.2%
Native Hawaiian or Other Pacific Islander
1
   0.6%
Black or African American
25
  15.0%
White
136
  81.4%
More than one race
3
   1.8%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 167 participants
167
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events
Hide Description [Not Specified]
Time Frame 6 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title DFN-02
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Active DFN-02

DFN-02: Active Experimental Drug

Overall Number of Participants Analyzed 167
Measure Type: Count of Participants
Unit of Measure: Participants
120
  71.9%
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DFN-02 (Single Arm, Open Label)
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Active DFN-02

DFN-02: Active Experimental Drug

All-Cause Mortality
DFN-02 (Single Arm, Open Label)
Affected / at Risk (%)
Total   0/167 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
DFN-02 (Single Arm, Open Label)
Affected / at Risk (%) # Events
Total   4/167 (2.40%)    
Cardiac disorders   
myocardial infarction   1/167 (0.60%) 
Gastrointestinal disorders   
Diverticulitis   1/167 (0.60%) 
cholecystitis   1/167 (0.60%) 
Renal and urinary disorders   
pyelonephritis   1/167 (0.60%) 
Reproductive system and breast disorders   
menometrorrhagia   1/167 (0.60%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DFN-02 (Single Arm, Open Label)
Affected / at Risk (%) # Events
Total   120/167 (71.86%)    
General disorders   
Application site pain   51/167 (30.54%)  568
Application Site Reaction   9/167 (5.39%)  32
Infections and infestations   
Upper Respiratory Tract Infection   18/167 (10.78%)  24
Nasopharyngitis   12/167 (7.19%)  13
Sinusitis   11/167 (6.59%)  12
Nervous system disorders   
dysgeusia   35/167 (20.96%)  232
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: Clinical Operations Director
Organization: Dr. Reddy's Laboratories
Phone: 609-282-1476
Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02279082     History of Changes
Other Study ID Numbers: DFN-02-CD-010
First Submitted: October 23, 2014
First Posted: October 30, 2014
Results First Submitted: March 2, 2017
Results First Posted: August 28, 2017
Last Update Posted: March 9, 2018