Clinical Trials Logo
  1. Home
  2. Seasonal Allergic Rhinitis
  3. NCT01651871
  4. Details
NCT01651871 Clinical Trial

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

Seasonal Allergic Rhinitis Clinical Trial

Official title:
A Phase 2, Multicenter, Parallel-Group, Randomized, Double-Blind, Placebo- And Active Comparator-Controlled, Combination Study Of S-555739 And Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01651871
Other study ID # 1210D1526
Secondary ID
Status Completed
Phase Phase 2
First received July 17, 2012
Last updated April 26, 2018
Start date July 2012
Est. completion date May 2013

Study information
Verified date April 2018
Source Shionogi Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 779
Est. completion date May 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• S-555739 Dose 1

• S-555739 Dose 2

• Cetirizine HCl Dose 1

• S-555739 placebo

• Cetirizine HCl placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shionogi

Outcome
Type Measure Description Time frame Safety issue
Primary Change in average morning/evening (AM/PM) reflective Total Nasal Symptom Score (rTNSS) Change from baseline through the 2-week treatment period (Day 2 through Day 15)
Primary Incidence of adverse events (AEs) From Screening period to Week 6 (Follow-up)
Secondary Change in average AM/PM instantaneous Total Nasal Symptom Score (iTNSS) Change from baseline through the 2-week treatment period (Day 2 through Day 15)
Secondary Change in average AM/PM Total Ocular Symptom Score Change from baseline through the 2-week treatment period (Day 2 through Day 15)
Secondary Assessment of Quality of Life Change from Week 3 to Week 5
Secondary Assessment of vital signs At Week 1 (Screening), Week 2, Week 3, Week 4, and Week 5
Secondary Assessment of clinical laboratory parameters At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up)
Secondary Assessment of electrocardiogram (ECG) findings At Week 1 (Screening) and Week 5
See also
  Status Clinical Trial Phase
Completed NCT01171664 - Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects Phase 2
Terminated NCT01337323 - Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting N/A
Completed NCT00784732 - A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber Phase 2
Completed NCT00619827 - Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract Phase 1
Completed NCT00578929 - Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients Phase 3
Completed NCT00209365 - The Role of Pollen Starch Granules in Pollen Challenge Studies in the Fraunhofer Environmental Exposure Unit N/A
Terminated NCT00223587 - Seasonal Allergic Rhinitis and Driving Ability Phase 4
Completed NCT00637455 - Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel Phase 4
Completed NCT00963599 - Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117) Phase 3
Recruiting NCT05346718 - Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis N/A
Completed NCT06126952 - Azelastine Allergen Chamber - Onset of Action Study Phase 2
Completed NCT02245360 - Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis Phase 3
Completed NCT01940146 - Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis Phase 2
Completed NCT01230619 - Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis Phase 2
Completed NCT00574210 - PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm) Phase 2
Completed NCT00561717 - A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis Phase 4
Completed NCT00405899 - Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections N/A
Completed NCT00420082 - A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber Phase 2
Completed NCT00443495 - Phase I/IIa Study on Chitin Microparticles in Subjects Suffering From Allergic Rhinitis Phase 1/Phase 2
Completed NCT03097432 - Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment N/A