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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 21, 2014