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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01651871
First Posted: July 27, 2012
Last Update Posted: May 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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. ( Shionogi ):

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) ]
  • Incidence of adverse events (AEs) [ Time Frame: From Screening period to Week 6 (Follow-up) ]

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) ]
  • 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) ]
  • Assessment of Quality of Life [ Time Frame: Change from Week 3 to Week 5 ]
  • Assessment of vital signs [ Time Frame: At Week 1 (Screening), Week 2, Week 3, Week 4, and Week 5 ]
  • Assessment of clinical laboratory parameters [ Time Frame: At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up) ]
  • Assessment of electrocardiogram (ECG) findings [ Time Frame: At Week 1 (Screening) and Week 5 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651871


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

Responsible Party: Shionogi
ClinicalTrials.gov Identifier: NCT01651871     History of Changes
Other Study ID Numbers: 1210D1526
First Submitted: July 17, 2012
First Posted: July 27, 2012
Last Update Posted: May 31, 2013
Last Verified: May 2013

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

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