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Completed

NCT Number: NCT01651871

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

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.

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Key information

Conditions

Seasonal Allergic Rhinitis Airway Obstruction Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Hypersensitivity Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Signs and Symptoms Signs and Symptoms, Respiratory Sneezing

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S-555739 Dose 1

Drug

S-555739 Dose 2

Drug

Cetirizine HCl Dose 1

Drug

S-555739 placebo

Drug

Cetirizine HCl placebo

Drug

Primary outcomes

  1. 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)

  2. Incidence of adverse events (AEs)

    Time frame: From Screening period to Week 6 (Follow-up)

Secondary outcomes

  1. 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)

  2. 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)

  3. Assessment of Quality of Life

    Time frame: Change from Week 3 to Week 5

  4. Assessment of vital signs

    Time frame: At Week 1 (Screening), Week 2, Week 3, Week 4, and Week 5

  5. Assessment of clinical laboratory parameters

    Time frame: At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up)

  6. Assessment of electrocardiogram (ECG) findings

    Time frame: At Week 1 (Screening) and Week 5

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jul 27, 2012
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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