Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,025

Participants

Timeline

Start Date

July 20, 2015

Primary Completion Date

November 9, 2018

Study Completion Date

November 19, 2018

Conditions
Rhinitis, Allergic, Seasonal
Interventions
BIOLOGICAL

Short ragweed pollen allergen extract

One sublingual tablet containing 12 units of Amb a 1-U, once daily (QD) for up to 35 weeks.

BIOLOGICAL

Placebo

One placebo sublingual tablet, QD for up to 35 weeks.

DRUG

Self-injectable epinephrine

Intramuscular (IM) injection with suggested doses of 0.15 mg for participants weighing 15-30 kg (33-66 pounds) or 0.3 mg for participants weighing ≥30 kg (≥66 pounds), as needed for severe allergic reactions. Epinephrine was only provided in countries/study sites where it was a regulatory requirement.

DRUG

Albuterol/Salbutamol

Inhalation of albuterol 90 mcg/puff or salbutamol 100 mcg/puff metered dose inhaler (MDI), as needed as asthma rescue medication for those participants with asthma

DRUG

Loratadine

5 mg (1 mg/mL syrup or 5 mg tablet) for participants 5 years old or 10 mg (1 mg/mL syrup or 10 mg tablet) for participants 6 to 17 years old, as needed for rhinoconjunctivitis symptoms

DRUG

Olopatadine

Opthalmic solution, 1 drop (0.1%) per affected eye twice daily (BID), as needed for rhinoconjunctivitis symptoms

DRUG

Mometasone furoate monohydrate

Intranasal spray, at doses of 1 spray (50 mcg/ spray) per nostril for participants 5 to 11 years old or 2 sprays (50 mcg/spray) per nostril for participants 12 to 17 years old, as needed for rhinoconjunctivitis symptoms

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02478398 - Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008) | Biotech Hunter | Biotech Hunter