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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )
ClinicalTrials.gov Identifier:
NCT01651871
First received: July 17, 2012
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: S-555739 Dose 1
Drug: S-555739 Dose 2
Drug: Cetirizine HCl Dose 1
Drug: S-555739 placebo
Drug: Cetirizine HCl placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:
  • Change in average morning/evening (AM/PM) reflective Total Nasal Symptom Score (rTNSS) [ Time Frame: Change from baseline through the 2-week treatment period (Day 2 through Day 15) ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) [ Time Frame: From Screening period to Week 6 (Follow-up) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in average AM/PM instantaneous Total Nasal Symptom Score (iTNSS) [ Time Frame: Change from baseline through the 2-week treatment period (Day 2 through Day 15) ] [ Designated as safety issue: No ]
  • Change in average AM/PM Total Ocular Symptom Score [ Time Frame: Change from baseline through the 2-week treatment period (Day 2 through Day 15) ] [ Designated as safety issue: No ]
  • Assessment of Quality of Life [ Time Frame: Change from Week 3 to Week 5 ] [ Designated as safety issue: No ]
  • Assessment of vital signs [ Time Frame: At Week 1 (Screening), Week 2, Week 3, Week 4, and Week 5 ] [ Designated as safety issue: Yes ]
  • Assessment of clinical laboratory parameters [ Time Frame: At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up) ] [ Designated as safety issue: Yes ]
  • Assessment of electrocardiogram (ECG) findings [ Time Frame: At Week 1 (Screening) and Week 5 ] [ Designated as safety issue: Yes ]

Enrollment: 779
Study Start Date: July 2012
Study Completion Date: May 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group 1 Drug: S-555739 Dose 1 Drug: Cetirizine HCl Dose 1
Experimental: Treatment Group 2 Drug: S-555739 Dose 2 Drug: Cetirizine HCl Dose 1 Drug: S-555739 placebo
Experimental: Treatment Group 3 Drug: S-555739 Dose 1 Drug: Cetirizine HCl placebo
Active Comparator: Treatment Group 4 Drug: Cetirizine HCl Dose 1 Drug: S-555739 placebo
Placebo Comparator: Treatment Group 5 Drug: S-555739 placebo Drug: Cetirizine HCl placebo

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651871

Sponsors and Collaborators
Shionogi
Investigators
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
  More Information

No publications provided

Responsible Party: Shionogi Inc. ( Shionogi )
ClinicalTrials.gov Identifier: NCT01651871     History of Changes
Other Study ID Numbers: 1210D1526
Study First Received: July 17, 2012
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Shionogi Inc.:
Agents, anti allergic
Nasal congestion
Sneezing
Nasal discharge
D prostanoid (DP) receptor antagonist

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Cetirizine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014