Seasonal Allergic RhinitisPhase 3NCT01413958
Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1)
A Phase 3 study testing Phenylephrine and Loratadine in people with Seasonal Allergic Rhinitis, run by Bayer.
Trial summary
This study will compare the nasal congestion symptom relief of phenylephrine extended release tablets and placebo in participants with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Phenylephrine and Loratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 575 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Oct 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understands study procedures and agrees to participate by giving signed consent form
- Male or female, aged 18 years or older, at the Screening Visit.
- Female participants must demonstrate a negative urine pregnancy test, at Screening (Visit 1) and Visit 2 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study and until 2 weeks after the last dose of study drug in the last treatment period. Acceptable methods of birth control are abstinence, or two of the following:
- hormonal contraceptives (with documented use for at least 30 days prior to Screening )
- intrauterine device (IUD)
- diaphragm with spermicide
Show all 19Show fewer
- contraceptive sponge
- condom
- vasectomy
- Willing to stop use of current decongestant and allergy medications during the trial
- Documented or self-reported history of allergic rhinitis caused by fall pollen within the last 4 years
- and documented or self-reported symptoms over at least the last 2 fall allergy seasons
- Documented skin testing (prick with wheal ≥3 mm larger than the diluent or intradermal with wheal ≥7 mm larger than the diluent control) within the last 4 years to fall pollen allergens present and prevalent in his/her geographic region.
- Signs and symptoms of nasal congestion (defined as stuffy or blocked nose) of at least mild severity (sign/symptom clearly present, but minimal awareness; easily tolerated) following the washout period (if applicable). Participant's diary evaluation must document at least mild symptoms for reflective and instantaneous scores on 4 consecutive days prior to randomization.
- Mean seated (after 5 minutes of rest) systolic/diastolic blood pressure ≤ 138/88 mmHg.
- Clinically acceptable physical exam and 12-lead ECG (recorded at 25 mm/s) that is clinically acceptable to the investigator.
- Free of any clinically significant disease that requires a physician's care and/or would interfere with trial evaluations, procedures, or participation.
- Agrees not to take monoamine oxidase inhibitors (MAOIs) from 14 days before trial participation until 14 days after the last dose of study drug.
- Capable of reading English.
Who cannot join
- Significant medical condition that is a contraindication to the use of phenylephrine, might
- interfere with the trial, or requires treatment expected to affect blood pressure
- History or presence of hypertension
- Started allergen immunotherapy within 1 month of enrollment, will start immunotherapy during
- the trial, or anticipates immunotherapy dose change during the trial
- Used Xolair (omalizumab) within 4 years prior to trial participation
Show all 19Show fewer
- Known allergy or intolerance to phenylephrine, loratadine, or desloratadine
- History of rhinitis medicamentosa
- Documented evidence of acute or significant chronic sinusitis
- Clinically significant nasal disorders such as deviated septum and nasal polyposis
- Asthma, with the exception of mild intermittent asthma
- Have used systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone
- permitted), or nasal corticosteroids in the last 30 days
- Mentally or legally incapacitated, has significant emotional problems at the time of the Screening Visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder over the last 5 years. Those who have had situational depression may be enrolled in the study at the discretion of the investigator.
- History of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- History of immunological disease or cancer within the past 5 years, with the exception of nonmelanoma skin cancer
- Positive drug screen (participants on prescribed medication resulting in a positive drug screen result may still be enrolled at the discretion of the investigator).
- Major surgery or participation in another investigational study within 30 days prior to the Screening Visit.
- Body mass index (BMI) ≥ 40
About this study
Official title: A Randomized, Placebo-Controlled Trial to Evaluate the Effects of Phenylephrine HCl 30 mg Extended-Release Tablets on Nasal Congestion in Subjects With Allergic Rhinitis
This study will compare the nasal congestion symptom relief of phenylephrine extended release tablets and placebo in participants with allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Phenylephrine, Placebo, Loratadine
- Keywords
- Nasal Decongestants, Rhinitis, Allergic, Seasonal, Rhinitis, Nose Conditions, Respiratory Tract Diseases, Phenylephrine
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Also called SCH 002063, MK-9314
Phenylephrine hydrochloride 30-mg extended-release tablets, one tablet every 12 hours for 7 days
PlaceboDrug
Placebo to phenylephrine hydrochloride 30-mg extended release tablets, one tablet every 12 hours for 7 days
LoratadineDrug
Also called Claritin®
Loratadine, 10 mg, once daily as rescue medication, only if needed for intolerable allergic rhinitis symptoms
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine | Experimental | Not described Receives: Drug: Phenylephrine; Drug: Loratadine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Loratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Daily Reflective Nasal Congestion Score
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.
Measured: Baseline and Days 1-7
Secondary outcomes (13)
Mean Change From Baseline in the Morning Reflective Symptom Assessment Score
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily morning nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.
Measured: Baseline and Days 1-7
Mean Change From Baseline in the Evening Reflective Symptom Assessment Score
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily evening nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.
Measured: Baseline and Days 1-7
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score
The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period.
Measured: Baseline and Days 1-7
Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.
Measured: Baseline and Day 1, 2, 3, 4, 5, 6, and 7
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day
The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.
Measured: Baseline and Day 1, 2, 3, 4, 5, 6, 7
Time to Maximal Phenylephrine Effect
The time to maximal phenylephrine effect was defined as the earliest time that the nasal congestion symptom score in the Phenylephrine treatment group demonstrated the greatest numerical difference from the Placebo treatment group in change from baseline. The mean change from baseline scores for a Phenylephrine treatment arm and for the Placebo treatment arm at each timepoint of the treatment period (Day 1 morning, Day 1 evening, etc) was calculated. The difference between the Phenylephrine treatment arm and Placebo treatment arm mean at each timepoint of the treatment period was calculated. The time to maximal phenylephrine effect was the first timepoint at which the difference between the Phenylephrine treatment arm and the Placebo treatment arm was greatest. The results for the Placebo treatment arm are not presented as the result of this outcome measure is only relevant for the Phenylephrine treatment group.
Measured: Baseline up to Day 7
Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score
The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period.
Measured: Baseline and Day 7
Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score
The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual morning instantaneous nasal scores was reported as the daily morning instantaneous nasal congestion score over the entire treatment period.
Measured: Baseline and Days 1-7
Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period.
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.
Measured: Baseline and Day 2, 3, 4, 5, 6, and 7
Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.
Measured: Baseline and Day 1, 2, 3, 4, 5, 6, and 7
Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period
The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.
Measured: Baseline and Day 2, 3, 4, 5, 6, and 7
Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period.
The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.
Measured: Baseline and Day 1, 2, 3, 4, 5, 6, and 7
Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ)
The RQLQ is a disease-specific quality of life questionnaire developed to measure the physical, emotional, and social problems in adults with rhinoconjunctivitis. Questions were divided into 7 domains: sleep (3 questions), non-hay fever symptoms (7 questions), practical problems (3
questions), nasal symptoms (4 questions), eye symptoms (4 questions), and activities (3 questions), and emotions (4 questions). Individual items within the RQLQ are equally weighted. The questionnaire is analyzed directly from the scores recorded and the results are expressed as the mean score for each of the domains (i.e., domain scores range from 0 to 6). Six represents the greatest impairment and 0 represents the least impairment. Overall quality of life score is the mean score for all domains.
Measured: Up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by BayerThe 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, Investigator
- Enrolment
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413958
- Sponsor's protocol ID
- 18125
- Other IDs
- CL2011-06, P08498
- Status last verified
- Feb 2015
- First submitted
- 9 Aug 2011
- Last updated
- 11 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Meltzer EO, Ratner PH, McGraw T. Phenylephrine hydrochloride modified-release tablets for nasal congestion: a randomized, placebo-controlled trial in allergic rhinitis patients. Ann Allergy Asthma Immunol. 2016 Jan;116(1):66-71. doi: 10.1016/j.anai.2015.10.022. Epub 2015 Nov 7.
PubMed 26560899
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Trial to Evaluate the Effects of Phenylephrine HCl 30 mg Extended-Release Tablets on Nasal Congestion in Subjects With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01413958
- Acronym / sponsor ID
- 18125
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Nasal Decongestants, Rhinitis, Allergic, Seasonal, Rhinitis, Nose Conditions, Respiratory Tract Diseases, Phenylephrine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Posted 29 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the nasal congestion symptom relief of phenylephrine extended release tablets and placebo in participants with allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine | Experimental | Drug: Phenylephrine, Drug: Loratadine |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Loratadine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Understands study procedures and agrees to participate by giving signed consent form
- Male or female, aged 18 years or older, at the Screening Visit.
- Female participants must demonstrate a negative urine pregnancy test, at Screening (Visit 1) and Visit 2 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study and until 2 weeks after the last dose of study drug in the last treatment period. Acceptable methods of birth control are abstinence, or two of the following:
- Willing to stop use of current decongestant and allergy medications during the trial
- Documented or self-reported history of allergic rhinitis caused by fall pollen within the last 4 years
Key exclusion criteria (19 listed)
- Significant medical condition that is a contraindication to the use of phenylephrine, might
- interfere with the trial, or requires treatment expected to affect blood pressure
- History or presence of hypertension
- Started allergen immunotherapy within 1 month of enrollment, will start immunotherapy during
- the trial, or anticipates immunotherapy dose change during the 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 |
|---|---|---|
| PhenylephrineAlso: SCH 002063, MK-9314Phenylephrine hydrochloride 30-mg extended-release tablets, one tablet every 12 hours for 7 days | Drug | Phenylephrine |
| PlaceboPlacebo to phenylephrine hydrochloride 30-mg extended release tablets, one tablet every 12 hours for 7 days | Drug | Placebo |
| LoratadineAlso: Claritin®Loratadine, 10 mg, once daily as rescue medication, only if needed for intolerable allergic rhinitis symptoms | Drug | Phenylephrine, Placebo |
Primary outcome
Mean Change From Baseline in Daily Reflective Nasal Congestion Score
Time frame: Baseline and Days 1-7
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.
13 secondary outcomes
Mean Change From Baseline in the Morning Reflective Symptom Assessment Score
Time frame: Baseline and Days 1-7
Mean Change From Baseline in the Evening Reflective Symptom Assessment Score
Time frame: Baseline and Days 1-7
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score
Time frame: Baseline and Days 1-7
Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day
Time frame: Baseline and Day 1, 2, 3, 4, 5, 6, and 7
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day
Time frame: Baseline and Day 1, 2, 3, 4, 5, 6, 7
Time to Maximal Phenylephrine Effect
Time frame: Baseline up to Day 7
Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score
Time frame: Baseline and Day 7
Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score
Time frame: Baseline and Days 1-7
Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period.
Time frame: Baseline and Day 2, 3, 4, 5, 6, and 7
Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period
Time frame: Baseline and Day 1, 2, 3, 4, 5, 6, and 7
Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period
Time frame: Baseline and Day 2, 3, 4, 5, 6, and 7
Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period.
Time frame: Baseline and Day 1, 2, 3, 4, 5, 6, and 7
Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ)
Time frame: Up to Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26560899Meltzer EO, Ratner PH, McGraw T. Phenylephrine hydrochloride modified-release tablets for nasal congestion: a randomized, placebo-controlled trial in allergic rhinitis patients. Ann Allergy Asthma Immunol. 2016 Jan;116(1):66-71. doi: 10.1016/j.anai.2015.10.022. Epub 2015 Nov 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phenylephrine and Loratadine in people with Seasonal Allergic Rhinitis, run by Bayer.
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 19 inclusion and 19 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 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 29 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Daily Reflective Nasal Congestion Score (time frame: Baseline and Days 1-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01413958, which also lists 1 linked publication.
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 11 Mar 2015.