Clinical Trial: Epinastine + Pseudoephedrine SR (Slow Release) Versus Epinastine Alone in Patients With Perennial Allergic Rhinitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Double-blind, Randomized, Parallel Trial to Evaluate the Clinical Efficacy and Safety of Epinastine 10 mg + Pseudoephedrine 120 mg SR, Twice a Day, Versus Epinastine 10 mg Alone, Twice a Day, in the T

Brief Summary: The aim of this trial is to evaluate the clinical efficacy and safety of Epinastine 10 mg + Pseudoephedrine 120 mg slow release (SR) administered twice a day, compared to Epinastine 10 mg alone administered twice daily.

Detailed Summary:
Sponsor: Boehringer Ingelheim

Current Primary Outcome:

  • Classification of severity of nasal blockage by Visual Analog Scale (VAS) [ Time Frame: at the end of weeks 1, 2, 3, 4 ]
  • Incidence of laboratory alterations [ Time Frame: day 14, 28 and 35 ]
  • Incidence of premature discontinuations of the study due to adverse events [ Time Frame: up to 4 weeks ]
  • Incidence and severity of all adverse events [ Time Frame: up to 5 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Daily evaluation of the nasal blockage by the patient [ Time Frame: daily up to 4 weeks ]
  • Classification of the severity of the symptoms by the investigator [ Time Frame: at the end of weeks 1, 2, 3, 4 ]
  • Changes in nasal physical examination [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  • Changes in rhinorrhea symptoms evaluated by investigator [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  • Changes in pruritus symptoms evaluated by investigator [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  • Changes in sneezing symptoms evaluated by investigator [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  • Changes in lacrimation symptoms evaluated by investigator [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  • Changes in rhinorrhea symptoms evaluated by patient using VAS [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  • Changes in pruritus symptoms evaluated by patient using VAS [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  • Changes in sneezing symptoms evaluated by patient using VAS [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  • Changes in lacrimation symptoms evaluated by patient using VAS [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]


Original Secondary Outcome: Same as current

Information By: Boehringer Ingelheim

Dates:
Date Received: July 2, 2014
Date Started: May 2000
Date Completion:
Last Updated: July 11, 2014
Last Verified: July 2014