NCT01306721

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

March 1, 2011

Last Update Submit

October 12, 2013

Conditions

Rhinitis Seasonal

Outcome Measures

Primary Outcomes (1)

  • Changes in the nasal congestion score based on the patient's symptom diary

    over 2 treatment weeks (from baseline to end of treatment)

Secondary Outcomes (7)

  • Changes in the total score of 4 symptoms, each nasal symptom (sneezing, rhinorrhea, and nasal congestion) and eye symptom

    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

    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

    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

    over 2 treatment weeks (from baseline to end of treatment)

  • Nasal findings

    over 2 treatment weeks (from baseline to end of treatment)

  • +2 more secondary outcomes

Study Arms (3)

FEX 60 mg

ACTIVE COMPARATOR

Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) Double-blind treatment period: 1 tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg /pseudoephedrine 60 mg (fixe dose combination)

Drug: fexofenadine HCL (M016455)Drug: pseudoephedrineDrug: fexofenadine HCL matching placeboDrug: pseudoephedrine matching placebo

FEX 60 mg/PSE 60 mg

EXPERIMENTAL

Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination Double-blind treatment period: 1 tablet of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 60 mg / pseudoephedrine 60 mg (fixe dose combination)

Drug: fexofenadine HCL (M016455)Drug: pseudoephedrineDrug: fexofenadine HCL matching placeboDrug: pseudoephedrine matching placebo

FEX 60 mg/PSE 120 mg

EXPERIMENTAL

Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) Double-blind treatment period: 2 tablets of fexofenadine 30 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 30 mg

Drug: fexofenadine HCL (M016455)Drug: pseudoephedrineDrug: fexofenadine HCL matching placebo

Interventions

fexofenadine HCL (M016455)DRUG

Pharmaceutical form:tablet Route of administration: oral

FEX 60 mgFEX 60 mg/PSE 120 mgFEX 60 mg/PSE 60 mg
pseudoephedrineDRUG

Pharmaceutical form:tablet Route of administration: oral

FEX 60 mgFEX 60 mg/PSE 120 mgFEX 60 mg/PSE 60 mg
fexofenadine HCL matching placeboDRUG

Pharmaceutical form:tablet Route of administration: oral

FEX 60 mgFEX 60 mg/PSE 120 mgFEX 60 mg/PSE 60 mg
pseudoephedrine matching placeboDRUG

Pharmaceutical form:tablet Route of administration: oral

FEX 60 mgFEX 60 mg/PSE 60 mg

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Investigational Site Number 392002

Koganeishi, Japan

Location

Investigational Site Number 392003

Osaka, Japan

Location

Investigational Site Number 392001

Shinjuku-Ku, Japan

Location

MeSH Terms

Interventions

fexofenadinePseudoephedrine

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylamines

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 2, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations

JP(3)