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Efficacy, Tolerability, and Safety Study of DFN-15

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: NCT03006276
Recruitment Status : Active, not recruiting
First Posted : December 30, 2016
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE December 27, 2016
First Posted Date  ICMJE December 30, 2016
Last Update Posted Date February 6, 2019
Study Start Date  ICMJE December 2016
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2016)
  • Proportion of subjects who are pain-free at 2 hours postdose (first double-blind treatment period) [ Time Frame: 2 hours post dose ]
  • Proportion of subjects who are free from their most bothersome symptom among nausea, photophobia, and phonophobia at 2 hours postdose (first double-blind treatment period. [ Time Frame: 2 hours post dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 27, 2016)
  • Proportion of subjects who are pain-free at 2 hours postdose (first double-blind treatment period) [ Time Frame: 2 days to 28 days, depending on when the first migraine is treated with study drug ]
  • Proportion of subjects who are free from their most bothersome symptom among nausea, photophobia, and phonophobia at 2 hours postdose (first double-blind treatment period. [ Time Frame: 2 days to 28 days, depending on when the first migraine is treated with study drug. ]
Change History Complete list of historical versions of study NCT03006276 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Tolerability, and Safety Study of DFN-15
Official Title  ICMJE Not Provided
Brief Summary Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being conducted at multiple centers in the United States.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine Headache
Intervention  ICMJE
  • Drug: DFN-15 Active
    Other Name: Celecoxib Oral Solution
  • Other: DFN-15 Placebo
Study Arms  ICMJE
  • Experimental: DFN-15 Active
    DFN-15 Active
    Intervention: Drug: DFN-15 Active
  • Placebo Comparator: DFN-15 Placebo
    DFN-15 Placebo
    Intervention: Other: DFN-15 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 22, 2017)
622
Original Estimated Enrollment  ICMJE
 (submitted: December 27, 2016)
600
Estimated Study Completion Date  ICMJE April 2019
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. A history of episodic migraine, who experience 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache-free time between migraine attacks.
  2. Patients who have migraine with or without aura with onset before age 50 years
  3. Report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale without treatment.
  4. Subjects who are willing and able to:

    1. Evaluate and record pain, migraine symptoms, and study drug effectiveness information in real-time using a subject eDiary for the duration of the study;
    2. Record each instance of the use of study drug and rescue medication in real-time using a subject eDiary for the duration of the study;
    3. Comply with all other study procedures and scheduling requirements.

Exclusion Criteria:

  1. Minors, even if they are in the specified study age range
  2. Medication overuse:

    1. Opioids greater than or equal to 10 days during the 90 days prior to screening
    2. Combination medications (e.g., Fiorinal®) greater than or equal to 10 days during the 90 days prior to screening (applies only if includes opioid and/or barbiturate)
    3. Nonsteroidal Anti-inflammatory Drugs or other simple medications greater than 14 days a month during the 90 days prior to screening
    4. Triptans or ergots greater than or equal to 10 days a month during the 90 days prior to screening
  3. Treated with onabotulinumtoxin A (Botox®) for migraine within 4 months prior to screening. (If treated for cosmetic reasons, subjects may be included).
  4. Current treatment with antipsychotics or use of antipsychotics within 30 days prior to randomization.
  5. Patients who have received treatment with an investigational drug or device within 30 days of randomization, or participated in a central nervous system clinical trial within 2 months prior to randomization
  6. Patients with positive screening test for human immunodeficiency virus [HIV], positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus [HCV] antibody
  7. Subjects who are employees or immediate relatives of the employees of the Sponsor, any of its affiliates or partners, or of the clinical research study site.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03006276
Other Study ID Numbers  ICMJE DFN-15-CD-007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dr. Reddy's Laboratories Limited
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP