Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00319995
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2006-04-28
Brief Title:
Effects of LoratadineMontelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis Study P04095 COMPLETED
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
Efficacy and Safety of Combination LoratadineMontelukast QD vs Pseudoephedrine and Placebo in the Treatment of Subjects With Seasonal Allergic Rhinitis
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 3 randomized parallel-group multicenter double-dummy double-blind study with a screening period Subjects will receive one of the following three treatment groups for 15 days loratadine 10 mgmontelukast 10 mg combination pseudoephedrine 240 mg or placebo The primary objective of this study is to assess the efficacy of the combination of loratadinemontelukast a once-daily tablet containing 10 mg loratadine and 10 mg montelukast compared with placebo in subjects with seasonal allergic rhinitis SAR in relieving the symptom of nasal congestion The safety profile of combined loratadinemontelukast relative to placebo and pseudoephedrine will also be evaluated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SCH 445761 | None | None | None |
| Doc ID 3058224 | None | None | None |