Rhinitis SeasonalPhase 3NCT01306721
Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis
A Phase 3 study testing fexofenadine HCL (M016455) and pseudoephedrine in people with Rhinitis Seasonal, run by Sanofi at 3 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rhinitis Seasonal
- What is being tested?
- fexofenadine HCL (M016455) and pseudoephedrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 3 sitesJapan
- Study dates
- Feb 2011to Apr 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Investigational Site Number 392002
Koganeishi
Investigational Site Number 392003
Osaka
Investigational Site Number 392001
Shinjuku-Ku
About this study
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
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.
Read the 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
- Conditions
- Rhinitis Seasonal
- Being tested
- fexofenadine HCL (M016455), pseudoephedrine, fexofenadine HCL matching placebo, pseudoephedrine matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fexofenadine HCL (M016455)Drug
Pharmaceutical form:tablet Route of administration: oral
pseudoephedrineDrug
Pharmaceutical form:tablet
Route of administration: oral
fexofenadine HCL matching placeboDrug
Pharmaceutical form:tablet
Route of administration: oral
pseudoephedrine matching placeboDrug
Pharmaceutical form:tablet
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: fexofenadine HCL (M016455); Drug: pseudoephedrine; Drug: fexofenadine HCL matching placebo; Drug: 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) Receives: Drug: fexofenadine HCL (M016455); Drug: pseudoephedrine; Drug: fexofenadine HCL matching placebo; Drug: 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 Receives: Drug: fexofenadine HCL (M016455); Drug: pseudoephedrine; Drug: fexofenadine HCL matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the nasal congestion score based on the patient's symptom diary
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: over 2 treatment weeks (from baseline to end of treatment)
Nasal findings
Measured: over 2 treatment weeks (from baseline to end of treatment)
Patient's impression
Measured: over 2 treatment weeks (from baseline to end of treatment)
Patient's safety
Measured: over 2 treatment weeks (from baseline to end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis SeasonalStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306721
- Sponsor's protocol ID
- EFC11243
- Other IDs
- U1111-1115-7613
- Status last verified
- Oct 2013
- First submitted
- 1 Mar 2011
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01306721
- Acronym / sponsor ID
- EFC11243
- Conditions
- Rhinitis Seasonal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FEX 60 mg | Active comparator | Drug: fexofenadine HCL (M016455), Drug: pseudoephedrine, Drug: fexofenadine HCL matching placebo, Drug: pseudoephedrine matching placeboStudy 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) |
| FEX 60 mg/PSE 60 mg | Experimental | Drug: fexofenadine HCL (M016455), Drug: pseudoephedrine, Drug: fexofenadine HCL matching placebo, Drug: pseudoephedrine matching placeboStudy 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) |
| FEX 60 mg/PSE 120 mg | Experimental | Drug: fexofenadine HCL (M016455), Drug: pseudoephedrine, Drug: fexofenadine HCL matching placeboStudy 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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- At the start of the placebo lead-in period:
- The last 3 days of the lead-in period:
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fexofenadine HCL (M016455)Pharmaceutical form:tablet Route of administration: oral | Drug | FEX 60 mg, FEX 60 mg/PSE 120 mg, FEX 60 mg/PSE 60 mg |
| pseudoephedrinePharmaceutical form:tablet Route of administration: oral | Drug | FEX 60 mg, FEX 60 mg/PSE 120 mg, FEX 60 mg/PSE 60 mg |
| fexofenadine HCL matching placeboPharmaceutical form:tablet Route of administration: oral | Drug | FEX 60 mg, FEX 60 mg/PSE 120 mg, FEX 60 mg/PSE 60 mg |
| pseudoephedrine matching placeboPharmaceutical form:tablet Route of administration: oral | Drug | FEX 60 mg, FEX 60 mg/PSE 60 mg |
Primary outcome
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)
7 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fexofenadine HCL (M016455) and pseudoephedrine in people with Rhinitis Seasonal, run by Sanofi at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.