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

NCT00378378 | Completed Phase 3 Results

• 1 other identifier: P04292
• Study Type: interventional
• Target: 127
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Change From Baseline 24-hour Urinary Free Cortisol Level

  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.

  Baseline to Endpoint

Secondary Outcomes (1)

• Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine

  Baseline to Endpoint

Study Arms (8)

MFNS 100 mcg QD for subjects 6 to less than 12 years

EXPERIMENTAL

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)

Placebo QD for subjects 6 to less than 12 years

PLACEBO COMPARATOR

Drug: Placebo nasal spray

MFNS 200 mcg QD for subjects 12 to less than 18 years

EXPERIMENTAL

Drug: Mometasone Furoate Nasal Spray (MFNS)

MFNS 200 mcg BID for subjects 12 to less than 18 years

EXPERIMENTAL

Drug: Mometasone Furoate Nasal Spray (MFNS)

Placebo QD for subjects 12 to less than 18 years

PLACEBO COMPARATOR

Drug: Placebo nasal spray

MFNS 100 mcg BID for subjects 6 to less than 12 years

EXPERIMENTAL

Drug: Mometasone Furoate Nasal Spray (MFNS)

Placebo BID for subjects 6 to less than 12 years

PLACEBO COMPARATOR

Drug: Placebo nasal spray

Placebo BID for subjects 12 to less than 18 years

PLACEBO COMPARATOR

Drug: Placebo nasal spray

Interventions

Mometasone Furoate Nasal Spray (MFNS) DRUG

100 mcg nasal spray

Also known as: Nasonex

MFNS 100 mcg BID for subjects 6 to less than 12 years; MFNS 100 mcg QD for subjects 6 to less than 12 years; MFNS 200 mcg BID for subjects 12 to less than 18 years; MFNS 200 mcg QD for subjects 12 to less than 18 years

Placebo nasal spray DRUG

One spray of placebo nasal spray in each nostril once daily for 4 months.

Placebo BID for subjects 12 to less than 18 years; Placebo BID for subjects 6 to less than 12 years; Placebo QD for subjects 12 to less than 18 years; Placebo QD for subjects 6 to less than 12 years

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Chur V, Small CB, Stryszak P, Teper A. Safety of mometasone furoate nasal spray in the treatment of nasal polyps in children. Pediatr Allergy Immunol. 2013 Feb;24(1):33-8. doi: 10.1111/pai.12032.

  PMID: 23331528 RESULT

MeSH Terms

Conditions

Nasal Polyps

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The standard deviation is pooled for Primary and Secondary Outcome Measures.

Results Point of Contact

• Title: Senior Vice Presiden, Global Clinical Development
• Organization: Merck, Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2006
• First Posted: September 20, 2006
• Study Start: July 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 20, 2024
• Results First Posted: July 20, 2010

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share