Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00378378
First received: September 18, 2006
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years old. Safety will be the primary focus of this study.


Condition Intervention Phase
Nasal Polyps
Drug: Mometasone Furoate Nasal Spray (MFNS)
Drug: Placebo nasal spray
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline 24-hour Urinary Free Cortisol Level [ Time Frame: Baseline to Endpoint ] [ Designated as safety issue: Yes ]
    The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to <18 years of age. Primary safety was to be assessed by determining the subject's 24-hour urinary free cortisol level.


Secondary Outcome Measures:
  • Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine [ Time Frame: Baseline to Endpoint ] [ Designated as safety issue: Yes ]
    The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine).


Enrollment: 127
Study Start Date: July 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MFNS 100 mcg QD for subjects 6 to less than 12 years
Mometasone Furoate nasal Spray (MFNS) 100 mcg once per day (QD) for subjects 6 to less than 12 years of age
Drug: Mometasone Furoate Nasal Spray (MFNS)
100 mcg nasal spray
Other Name: Nasonex
Placebo Comparator: Placebo QD for subjects 6 to less than 12 years Drug: Placebo nasal spray
One spray of placebo nasal spray in each nostril once daily for 4 months.
Experimental: MFNS 200 mcg QD for subjects 12 to less than 18 years Drug: Mometasone Furoate Nasal Spray (MFNS)
100 mcg nasal spray
Other Name: Nasonex
Experimental: MFNS 200 mcg BID for subjects 12 to less than 18 years Drug: Mometasone Furoate Nasal Spray (MFNS)
100 mcg nasal spray
Other Name: Nasonex
Placebo Comparator: Placebo QD for subjects 12 to less than 18 years Drug: Placebo nasal spray
One spray of placebo nasal spray in each nostril once daily for 4 months.
Experimental: MFNS 100 mcg BID for subjects 6 to less than 12 years Drug: Mometasone Furoate Nasal Spray (MFNS)
100 mcg nasal spray
Other Name: Nasonex
Placebo Comparator: Placebo BID for subjects 6 to less than 12 years Drug: Placebo nasal spray
One spray of placebo nasal spray in each nostril once daily for 4 months.
Placebo Comparator: Placebo BID for subjects 12 to less than 18 years Drug: Placebo nasal spray
One spray of placebo nasal spray in each nostril once daily for 4 months.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A subject must be 6 to <18 years of age, of either sex, and of any race.
  • A subject must have a diagnosis of bilateral nasal polyps.
  • A subject must have a minimum nasal congestion/obstruction
  • An asthmatic subject may be included.
  • A subject's clinical laboratory tests (hematology, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor.
  • The subject and parent/guardian must be willing to give written informed consent, and the subject must be able to adhere to dose and visit schedules.
  • A female subject of child-bearing potential who is sexually active must have been using a medically accepted method of contraception prior to Screening and must continue using it while receiving protocol-specified medication. If a pre-menarche female subject begins menstruating during the study, a serum pregnancy test must be done at the next visit

Exclusion Criteria:

  • A subject with antrochoanal polyps.
  • A subject with cystic fibrosis.
  • A subject with acute sinusitis, concurrent upper respiratory tract infection, or who had an upper respiratory tract infection within 2 weeks prior to the Screening Visit.
  • A subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
  • A subject who is immunocompromised.
  • A subject with ongoing rhinitis medicamentosa.
  • A subject with Churg Strauss syndrome.
  • A subject with dyskinetic ciliary syndromes, eg, Young's syndrome (sinopulmonary infections and obstructive azoospermia) or Kartagener's syndrome (immotile cilia).
  • A subject with any clinically significant pretreatment laboratory, vital sign, or ECG abnormality.
  • A subject with allergy/sensitivity to aspirin, corticosteroids, or study drug or its excipients.
  • A subject who has not observed the medication washout times outlined in the protocol prior to the Screening Visit.
  • A female subject who is breast-feeding, pregnant, or intends to become pregnant.
  • A subject who has used any investigational drug within 30 days of Screening.
  • A subject who is part of the staff personnel directly involved with this study.
  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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00378378     History of Changes
Other Study ID Numbers: P04292
Study First Received: September 18, 2006
Results First Received: June 24, 2009
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nasal Polyps
Polyps
Nose Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Respiratory Tract Diseases
Mometasone furoate
Anti-Allergic Agents
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014