Phase 3
N=689
Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00968201 ↗Enrolled (actual)
689
Serious AEs
9.5%
Results posted
Aug 2010
Primary outcome: Primary: Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study — 202; 406; 26; 55 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- montelukast sodium (Drug); Comparator: Placebo (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Mar 2001
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study |
202; 406; 26; 55 | — |
| SECONDARY Number of Patients With Drug-related CAEs Reported by Patients - Base Study |
9; 19; 219; 442 | — |
| SECONDARY Number of Patients With Serious CAEs Reported by Patients - Base Study |
9; 17; 219; 444 | — |
| SECONDARY Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study |
0; 2; 228; 459 | — |
| SECONDARY Number of Patients Who Were Discontinued Due to CAEs - Base Study |
7; 16; 221; 445 | — |
| SECONDARY Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study |
1; 2; 227; 459 | — |
| SECONDARY Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study |
2; 8; 226; 453 | — |
| SECONDARY Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study |
12; 16; 212; 435 | — |
| SECONDARY Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study |
1; 7; 223; 444 | — |
| SECONDARY Number of Patients Who Were Discontinued Due to LAEs - Base Study |
1; 0; 223; 451 | — |
| SECONDARY Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study |
1; 0; 223; 451 | — |
| SECONDARY Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension |
149; 353; 8; 11 | — |
| SECONDARY Number of Patients With Drug-related CAEs Reported by Patients - Extension |
2; 14; 155; 350 | — |
| SECONDARY Number of Patients With Serious CAEs Reported by Patients - Extension |
15; 38; 142; 326 | — |
| SECONDARY Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension |
0; 4; 157; 360 | — |
| SECONDARY Number of Patients Who Were Discontinued Due to CAEs - Extension |
5; 18; 152; 346 | — |
| SECONDARY Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension |
0; 2; 157; 362 | — |
| SECONDARY Number of Patients Who Were Discontinued Due to Serious CAEs - Extension |
1; 9; 156; 355 | — |
| SECONDARY Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension |
0; 1; 157; 363 | — |
| SECONDARY Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension |
14; 42; 140; 315 | — |
| SECONDARY Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension |
0; 7; 154; 350 | — |
| SECONDARY Number of Patients With Serious LAEs - Extension |
0; 1; 154; 356 | — |
| SECONDARY Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension |
0; 1; 154; 356 | — |
| SECONDARY Number of Patients Who Were Discontinued Due to LAEs - Extension |
0; 4; 154; 353 | — |
| SECONDARY Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension |
0; 4; 154; 353 | — |
| SECONDARY Number of Patients Who Were Discontinued Due to Serious LAEs - Extension |
0; 1; 154; 356 | — |
| SECONDARY Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension |
0; 1; 154; 356 | — |
Summary
A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.
Eligibility Criteria
Inclusion Criteria
- Patient has history of physician diagnosed asthma
- Patient is in otherwise good stable health
- Patient is able to chew a tablet
Exclusion Criteria
- Patient is hospitalized
- Patient and/or parent of guardian intends to move or vacation away from home during the course of the study
- Patient had any major surgical procedure within 4 weeks before the study
- Patient had active sinus disease within 3 weeks before the study
- Patient had required intubation for asthma in the past
- Patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study
- Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study
Data sourced from ClinicalTrials.gov (NCT00968201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.