CompletedPhase 4

Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)

34 participantsStarted 2008-08-01

Plain-language summary

To document the short term \& long term effect of treatment with Nasonex (mometasone furoate nasal spray) in moderate to severe adenoids hypertrophy (which cause \> 50% obstruction of the posterior choanae).

Who can participate

Age range2 Years – 11 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy \> 50% of posterior choanae. Exclusion Criteria: * adenoids hypertrophy \< 50% of posterior choanae recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic otitis media, cystic fibrosis, acute infection.

What they're measuring

Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score

Timeframe: Baseline and Week 12

Degree of Posterior Choana Obstruction at Baseline and Week 12

Timeframe: Baseline and Week 12

Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy

Timeframe: Baseline to 12 weeks

Trial details

NCT IDNCT01098071

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-09-01

Results submitted2011-06-13

View on ClinicalTrials.gov More Adenoids trials