Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rhinitis Seasonal |
Drug: fexofenadine HCL (M016455) Drug: pseudoephedrine Drug: fexofenadine HCL matching placebo Drug: pseudoephedrine matching placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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 |
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- Nasal findings [ Time Frame: over 2 treatment weeks (from baseline to end of treatment) ] [ Designated as safety issue: No ]
- Patient's impression [ Time Frame: over 2 treatment weeks (from baseline to end of treatment) ] [ Designated as safety issue: No ]
- Patient's safety [ Time Frame: over 2 treatment weeks (from baseline to end of treatment) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 520 |
| Study Start Date: | February 2011 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: FEX 60 mg
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)
Pharmaceutical form:tablet Route of administration: oral
Drug: pseudoephedrine
Pharmaceutical form:tablet Route of administration: oral Pharmaceutical form:tablet Route of administration: oral Pharmaceutical form:tablet Route of administration: oral |
|
Experimental: FEX 60 mg/PSE 60 mg
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)
Pharmaceutical form:tablet Route of administration: oral
Drug: pseudoephedrine
Pharmaceutical form:tablet Route of administration: oral Pharmaceutical form:tablet Route of administration: oral Pharmaceutical form:tablet Route of administration: oral |
|
Experimental: FEX 60 mg/PSE 120 mg
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)
Pharmaceutical form:tablet Route of administration: oral
Drug: pseudoephedrine
Pharmaceutical form:tablet Route of administration: oral Pharmaceutical form:tablet Route of administration: oral |
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Japan | |
| Investigational Site Number 392002 | |
| Koganei-Shi, Japan, 184-0005 | |
| Investigational Site Number 392003 | |
| Osaka-Shi, Japan, 532-0003 | |
| Investigational Site Number 392001 | |
| Shinjuku-Ku, Japan, 160-0022 | |
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Trial Transparency Team, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT01306721 History of Changes |
| Other Study ID Numbers: | EFC11243, U1111-1115-7613 |
| Study First Received: | March 1, 2011 |
| Last Updated: | May 6, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Rhinitis, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections Pseudoephedrine Ephedrine Fexofenadine Terfenadine Nasal Decongestants |
Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Central Nervous System Stimulants Central Nervous System Agents Sympathomimetics Adrenergic Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 23, 2013