Combination Study Of S-555739/Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis

Shionogi

Status and phase: Completed; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: S-555739 Dose 2; Drug: Cetirizine HCl Dose 1; Drug: S-555739 placebo; Drug: S-555739 Dose 1; Drug: Cetirizine HCl placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01651871

1210D1526

Details and patient eligibility

About

The primary objective of the study was to examine the efficacy and safety of S-555739/cetirizine HCl compared with the individual components and placebo.

Enrollment: 779 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History and diagnosis of seasonal allergic rhinitis by skin prick test
• Have nasal symptom scores as defined by the study protocol
• Able to comply with study procedures

Exclusion criteria

• Any nasal disease or abnormality, active respiratory tract infections within the past 2 weeks, or recent nasal surgery or sinus surgery at Screening
• Use of any prohibited concomitant drugs or therapies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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779 participants in 5 patient groups, including a placebo group

Treatment Group 1

Experimental group

Treatment:

Drug: S-555739 Dose 1

Drug: Cetirizine HCl Dose 1

Treatment Group 2

Experimental group

Treatment:

Drug: S-555739 placebo

Drug: Cetirizine HCl Dose 1

Drug: S-555739 Dose 2

Treatment Group 3

Experimental group

Treatment:

Drug: Cetirizine HCl placebo

Drug: S-555739 Dose 1

Treatment Group 4

Active Comparator group

Treatment:

Drug: S-555739 placebo

Drug: Cetirizine HCl Dose 1

Treatment Group 5

Placebo Comparator group

Treatment:

Drug: S-555739 placebo

Drug: Cetirizine HCl placebo