fexofenadine HCL (M016455)
DrugPharmaceutical form:tablet Route of administration: oral
Completed
NCT Number: NCT01306721
Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis
Primary Objective:
- To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg - pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg - pseudoephedrine HCl 120 mg combination (FEX60/PSE120) versus fexofenadine HCl 60 mg (FEX60) in patients with seasonal allergic rhinitis (SAR).
Secondary Objectives:
* To evaluate the efficacy of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60 on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily activity impairment. * To assess the safety of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60.
Completed
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Notify MeKey information
Conditions
Age range
12 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Investigational Site Number 392002, Koganeishi, Japan
Loading trial locations.
About this study
The study duration for each patient is 3 weeks and 3 days:
- Lead-in period: 1 week
- Treatment period: 2 weeks
- Follow-up period: 3 days
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients with seasonal allergic rhinitis (SAR): Patients with a history of SAR symptoms during the season when cedar pollen levels are increased for at least 2-years
Exclusion criteria
- At the start of the placebo lead-in period:
- Patients who are negative for IgE Antibody test
- Expected nasal congestion score is less than 2
- The last 3 days of the lead-in period:
- Nasal congestion scores are 2 or more and not all 4
- Patients with all nasal symptoms (sneezing, rhinorrhea, and nasal congestion). A total score for nasal symptoms (sneezing, rhinorrhea, and nasal congestion) and eye symptom is less than 6
- Patients with 2 or more nasal symptoms (sneezing and rhinorrhea) and eye symptoms score is 4
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Treatment and study plan
pseudoephedrine
DrugPharmaceutical form:tablet
Route of administration: oral
fexofenadine HCL matching placebo
DrugPharmaceutical form:tablet
Route of administration: oral
pseudoephedrine matching placebo
DrugPharmaceutical form:tablet
Route of administration: oral
Primary outcomes
-
Changes in the nasal congestion score based on the patient's symptom diary
Time frame: over 2 treatment weeks (from baseline to end of treatment)
Secondary outcomes
-
Changes in the total score of 4 symptoms, each nasal symptom (sneezing, rhinorrhea, and nasal congestion) and eye symptom
Time frame: over 2 treatment weeks (from baseline to end of treatment)
-
Changes in total score of 4 symptoms on a daily, day-time, and night-time bases
Time frame: over 2 treatment weeks (from baseline to end of treatment)
-
Changes in each symptom (sneezing, rhinorrhea, nasal congestion, and eye symptoms) score and the daily activity impairment score
Time frame: over 2 treatment weeks (from baseline to end of treatment)
-
Changes in each symptom score and the daily activity impairment score on a daily, day-time and night-time basis
Time frame: over 2 treatment weeks (from baseline to end of treatment)
-
Nasal findings
Time frame: over 2 treatment weeks (from baseline to end of treatment)
-
Patient's impression
Time frame: over 2 treatment weeks (from baseline to end of treatment)
-
Patient's safety
Time frame: over 2 treatment weeks (from baseline to end of treatment)
Interested in participating?
Completed
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Lead sponsor
Sanofi
Industry
Registry information
Official study title
A Randomized, Double Blind, Parallel Group Study for Assessing the Efficacy and Safety of a Twice-daily Fexofenadine HCl 60 mg - Pseudoephedrine HCl 60 mg Combination or Fexofenadine HCl 60 mg - Pseudoephedrine HCl 120 mg Combination Versus Allegra® 60 mg in Patients With Seasonal Allergic Rhinitis
Important dates
- Study start
- 2011
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Mar 2, 2011
- Registry last updated
- Oct 16, 2013
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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