<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01673659</url>
  </required_header>
  <id_info>
    <org_study_id>PRG-NY-12-008</org_study_id>
    <nct_id>NCT01673659</nct_id>
  </id_info>
  <brief_title>A Safety and Bioequivalence of a Mometasone Nasal Spray, 50 mcg/Actuation Compared With Nasonex® Nasal Spray 50 mcg/Actuation in the Relief of the Symptoms of Seasonal Allergic Rhinitis (SAR)</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Padagis LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Padagis LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study is to demonstrate bioequivalence (comparable safety and&#xD;
      efficacy) of the Test product to the Reference in the treatment of subjects seasonal allergic&#xD;
      rhinitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change from Baseline for mean reflective Total Nasal Symptom Score (rTNSS)</measure>
    <time_frame>2 week treatment period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change from Baseline in the mean Instantaneous Total Nasal Symptom Score (iTNSS)</measure>
    <time_frame>2 weeks treatment period</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1220</enrollment>
  <condition>Seasonal Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>Test product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mometasone furoate 50 mcg/actuation Nasal Spray</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference product</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nasonex Nasal Spray</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Nasal Spray</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>vehicle of the test product</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mometasone furoate</intervention_name>
    <arm_group_label>Test product</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nasonex Nasal Spray</intervention_name>
    <arm_group_label>Reference product</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo nasal spray</intervention_name>
    <arm_group_label>Placebo Nasal Spray</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Complete the informed consent/assent process.&#xD;
&#xD;
          2. Male or female between 12-65 years of age.&#xD;
&#xD;
          3. Female subjects of child-bearing potential must not be pregnant or nursing, must have&#xD;
             a negative urine pregnancy test and abstain from sexual intercourse or use a reliable&#xD;
             method of contraception during the study.&#xD;
&#xD;
          4. Subjects will be eligible to participate if: a) Their total rTNSS is at least 6; b)&#xD;
             Reflective rating for &quot;nasal congestion/stuffy nose&quot; is a score of &gt;2 at Visit 1; c)&#xD;
             Reflective score of &gt;2 for at least one (1) of the remaining three (3) allergic&#xD;
             rhinitis symptoms.&#xD;
&#xD;
          5. A history (2 or more seasons) of seasonal allergy to at least one allergen known to be&#xD;
             present during the study season, confirmed by a skin prick test. (A documented&#xD;
             positive skin test within the previous 12 months is acceptable.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female who is pregnant or nursing, who is not using or does not agree to use an&#xD;
             acceptable form of contraception during the study, or who intends to become pregnant&#xD;
             during the study.&#xD;
&#xD;
          2. Subject has a history of hypersensitivity or allergy to Mometasone, any other&#xD;
             corticosteroids or any of the other study medication ingredients.&#xD;
&#xD;
          3. Patients who suffer from chronic signs and symptoms of Perennial Allergic Rhinitis&#xD;
             (PAR) should be excluded from the study, unless the Investigator assesses that the&#xD;
             patient's current signs and symptoms are a clear exacerbation of Seasonal Allergic&#xD;
             Rhinitis (SAR), rather than chronic PAR.&#xD;
&#xD;
          4. A total score of less than 6 on the rTNSS or a score less than 2 for &quot;nasal&#xD;
             congestion&quot; or a score less than 2 for all of the remaining 3 symptoms.&#xD;
&#xD;
          5. Subject has any condition or abnormality of the upper airway (ex: nasal polyps,&#xD;
             obstruction, recent nasal surgery, structural abnormality, rhinitis medicamentosa,&#xD;
             etc.) that, in the opinion of the Investigator, could interfere with administration of&#xD;
             the product, evaluation of the subject's condition, or other aspect of the trial.&#xD;
&#xD;
          6. Subject has experienced any upper respiratory tract infection or has experienced a&#xD;
             sinus infection within the 30 days, or has a history of recurrent sinus infections&#xD;
             i.e. acute or significant chronic sinusitis, preceding Visit 1.&#xD;
&#xD;
          7. Subject has a history of asthma requiring chronic treatment within two years of study&#xD;
             start.&#xD;
&#xD;
          8. Subject lacks history of seasonal allergy to at least one allergen known to be present&#xD;
             during the study season for at least the two preceding seasons.&#xD;
&#xD;
          9. Subject has a negative skin test for all appropriate allergens known to be present&#xD;
             during the study season.&#xD;
&#xD;
         10. Treatment for oral Candidiasis within 30 days of starting the study, or a current oral&#xD;
             Candidiasis infection.&#xD;
&#xD;
         11. The subject has had recent exposure (30 days) or is at risk of being exposed to&#xD;
             chicken pox or measles.&#xD;
&#xD;
         12. Patients with any untreated fungal, bacterial, systemic viral infections within the&#xD;
             previous 30 days.&#xD;
&#xD;
         13. Subject requires treatment with systemic corticosteroids for any condition, or has&#xD;
             received systemic or nasal steroids within the 30 days preceding Visit 1. Hormone&#xD;
             replacement therapy is allowed, on condition that the subject has been on a stable&#xD;
             dosing regimen for at least 90 days and remains on the same dosing regimen during the&#xD;
             study.&#xD;
&#xD;
         14. Subject used systemic anti-inflammatory agents* including aspirin** and non-steroidal&#xD;
             anti-inflammatory (NSAIDs) within 3 days prior to Visit 1. (*Subjects may use&#xD;
             Acetaminophen for pain relief, as needed, throughout the study. **Use of low-dose&#xD;
             aspirin for cardiac prophylaxis is allowed).&#xD;
&#xD;
         15. Subject had immunotherapy (including desensitization therapy to perennial allergens or&#xD;
             seasonal allergens not found in the current season) initiated or the subject's dosage&#xD;
             or frequency of immunotherapy has been adjusted within the 30 days preceding Visit 1.&#xD;
&#xD;
         16. Subject had desensitization therapy to the seasonal allergen that is causing their&#xD;
             allergic rhinitis within the previous 6 months.&#xD;
&#xD;
         17. Subject presented with conjunctivitis or any other eye signs/symptoms that are not&#xD;
             related to the diagnosis of SAR.&#xD;
&#xD;
         18. Subject has used a topical (&gt;1%) or ophthalmic steroid preparation within 14 days&#xD;
             preceding Visit 1. (Topical steroid preparations used for dermatological indications&#xD;
             are permitted in concentrations of ≤1%.)&#xD;
&#xD;
         19. Use of intranasal or systemic first generation anti-histamines, leukotriene receptor&#xD;
             antagonists (montelukast) or other nasal decongestants within 3 days of Visit 1.&#xD;
&#xD;
         20. Use of intranasal cromolyn within 14 days of Visit 1.&#xD;
&#xD;
         21. Use of intranasal or systemic second-generation antihistamines (e.g. fexofenadine,&#xD;
             loratadine, desloratadine, cetirizine) within 10 days of Visit 1.&#xD;
&#xD;
         22. Subject has received immune-system therapy with AIC (an investigational vaccine&#xD;
             created using immunostimulatory sequences derived from DNA), SLIT, Oral peptide&#xD;
             sequence at any time.&#xD;
&#xD;
         23. Subject has clinically significant acute or chronic hepatic disease.&#xD;
&#xD;
         24. Subject has a history of alcoholism, drug abuse, or problems which would likely make&#xD;
             him/her unreliable for the study.&#xD;
&#xD;
         25. Subject has any condition or uses any medication which, in the opinion of the&#xD;
             Investigator, might interfere with the conduct or results of the study or place the&#xD;
             prospective subject at increased risk.&#xD;
&#xD;
         26. Subject has received tricyclic antidepressants within the 30 days preceding Visit 1.&#xD;
&#xD;
         27. Subject has been treated for attention-deficit hyperactivity disorder with an unstable&#xD;
             dose of a methylphenidate-containing products during the 30 days preceding Visit 1, or&#xD;
             a dose adjustment is anticipated during the study.&#xD;
&#xD;
         28. Subject or the subject's parent/legal guardian is unwilling to sign the informed&#xD;
             consent form.&#xD;
&#xD;
         29. Subject is concurrently participating in another investigational study or using any&#xD;
             investigational drug (or biologic) or device within the 30 days prior to Visit 1.&#xD;
&#xD;
         30. Subject plans or anticipates travel outside the allergen-rich area for more than one&#xD;
             day during the Run-In phase (Visit 1-Visit 2), or for more than two consecutive and&#xD;
             three total days during the Treatment Period (Visit 2-Visit 3). (Whenever possible,&#xD;
             subjects should remain in the allergen-rich area for the 3 days preceding Visit 2 and&#xD;
             Visit 3.)&#xD;
&#xD;
         31. Subject has a history or presence of cataracts, ocular herpes, or glaucoma.&#xD;
&#xD;
         32. Subject has a history of tuberculosis.&#xD;
&#xD;
         33. Subject has previously enrolled in this study.&#xD;
&#xD;
         34. Subject has used the Reference Product (Nasonex) within 3 months prior to Visit 1.&#xD;
&#xD;
         35. History of unresponsiveness to Mometasone Nasal Spray.&#xD;
&#xD;
         36. Members of the Investigational study staff, or family members of the Investigational&#xD;
             study staff.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <disposition_first_submitted>September 23, 2013</disposition_first_submitted>
  <disposition_first_submitted_qc>September 23, 2013</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 1, 2013</disposition_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
    <mesh_term>Rhinitis, Allergic, Seasonal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mometasone Furoate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01673659
org study id: PRG-NY-12-008
nct id: NCT01673659
lead sponsor: 
has dmc: No
The objectives of this study is to demonstrate bioequivalence (comparable safety and
      efficacy) of the Test product to the Reference in the treatment of subjects seasonal allergic
      rhinitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mean Change from Baseline for mean reflective Total Nasal Symptom Score (rTNSS)
time frame: 2 week treatment period
measure: Mean Change from Baseline in the mean Instantaneous Total Nasal Symptom Score (iTNSS)
time frame: 2 weeks treatment period
arm group label: Test product
arm group type: Experimental
description: Mometasone furoate 50 mcg/actuation Nasal Spray
arm group label: Reference product
arm group type: Active Comparator
description: Nasonex Nasal Spray
arm group label: Placebo Nasal Spray
arm group type: Placebo Comparator
description: vehicle of the test product
intervention type: Drug
intervention name: Mometasone furoate
arm group label: Test product
intervention type: Drug
intervention name: Nasonex Nasal Spray
arm group label: Reference product
intervention type: Drug
intervention name: Placebo nasal spray
arm group label: Placebo Nasal Spray
criteria: 
gender: All
minimum age: 12 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Seasonal
mesh term: Mometasone Furoate