Equivalency Study of Two Formulations of Mometasone Furoate Nasal Spray (Study P04419)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00779740
First received: October 23, 2008
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

This is a multicenter, open-label, randomized, parallel group comparison study to verify the clinical equivalency of the old formulation (50 mcg as mometasone furoate [MF] in 50 μL of solution per spray) to the new formulation (50 mcg as MF in 100 μL of solution per spray) in patients with perennial allergic rhinitis.


Condition Intervention Phase
Rhinitis, Allergic, Perennial
Drug: mometasone furoate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Equivalency Study of Two Formulations of Mometasone Furoate Nasal Spray

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in 4 nasal symptom score (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) from baseline at Week 2. [ Time Frame: After 2 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in each nasal symptom (sneezing attack, rhinorrhea, nasal congestion, and nasal itching). [ Time Frame: After 2 weeks of treatment ] [ Designated as safety issue: No ]
  • Overall improvement [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: From initial day of treatment until treatment is stopped. ] [ Designated as safety issue: Yes ]
  • Laboratory tests [ Time Frame: At 7 or more days before treatment start, and after 2 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 102
Study Start Date: February 2005
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New Formulation Group Drug: mometasone furoate
The dose will be 50 mcg as MF in one spray (100 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg.
Other Names:
  • Nasonex
  • SCH 32088
Active Comparator: Old Formulation Group Drug: mometasone furoate
The dose will be 50 mcg as MF in one spray (50 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg.
Other Names:
  • Nasonex
  • SCH 32088

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of mongoloid race residing in Japan who satisfy all of the following criteria:

    • Patients having symptoms of perennial allergic rhinitis of moderate or severe degree, according to the classification of severity in the guidelines for the treatment of nasal allergy (partial revision) as well as a score of at least 4 in the score of 4 nasal symptoms, at the time of obtaining informed consent and during the pretreatment observation period.
    • Patients with a positive skin reaction test or specific IgE antibody quantitation, and with a positive cytological examination of nasal discharge (eosinophils) or nasal challenge test.
    • Outpatients who are at least 16 years of age at the time of informed consent obtained.
    • Male or female.
    • Patients who have the ability to give written informed consent (informed consent of the guardian must also be obtained for patients younger than 20 years).
    • Patients who can keep nasal allergy diary without fail.

Exclusion Criteria:

  • Patients with coexisting tuberculous disease or lower respiratory tract infection, or patients who, at the time of registration, have acute upper respiratory tract infection, acute pharyngitis, acute amygdalitis etc.
  • Patients with coexisting infections or systemic mycosis for which there are no effective antibiotics.
  • Patients with unhealed nasal septum ulcers, nasal surgery scar, or nasal trauma.
  • Patients with a history of hypersensitivity to steroids or mometasone furoate.
  • Patients who are pregnant or nursing or who may be pregnant and patients or patients' partners who desire to become pregnant during the study period.
  • Patients with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension or other serious coexisting diseases and whose general condition is poor.
  • Patients also allergic to pollen and the pollen release season occurs during the study period.
  • Patients with vasomotor rhinitis or eosinophilic rhinitis.
  • Patients with a nasal condition which may interfere with efficacy evaluation of the investigational product.
  • Patients who develop disease affecting nasal symptoms during the pretreatment observation period, i.e., during the 7 days before actual registration.
  • Patients who are participating or have participated in a clinical trial of another investigational drug within 120 days (4 months) before the day of the informed consent for this study.
  • Patients for whom the period of discontinuation of previous treatment effective for allergic rhinitis before the start of the investigational product administration is not sufficient or who cannot avoid its use.
  • Patients receiving specific desensitization therapy or nonspecific modulation therapy or who had just discontinued such therapies within 90 days (3 months) before providing consent to this study (unless such therapies are ongoing as maintenance therapy and had been started 180 days [6 months] or more before consent to this study).
  • Other patients judged inappropriate for study by the investigator or subinvestigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00779740     History of Changes
Other Study ID Numbers: P04419, JPC-04-342-41
Study First Received: October 23, 2008
Last Updated: May 1, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Rhinitis
Mometasone furoate
Anti-Allergic Agents
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014