Allergic RhinitisPhase 4NCT02932774
Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-Center Study of the Efficacy and Safety of Cetirizine HCl Syrup vs. Loratadine Syrup vs. Placebo in Treatment of Children With Seasonal Allergic Rhinitis (SAR)
A Phase 4 study testing Cetirizine and Loratadine in people with Allergic Rhinitis and Hay Fever, run by Johnson & Johnson Consumer and Personal Products Worldwide.
Trial summary
The objective of this clinical trial was to assess the efficacy and safety of cetirizine HCl syrup vs. loratadine syrup vs. placebo syrup in the treatment of SAR in children 6 to 11 years old. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Allergic Rhinitis, Hay Fever, SAR
- What is being tested?
- Cetirizine and Loratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 683 participants
- Where
- No sites listed yet
- Study dates
- Mar 2001to Jul 2001
- Phase
- Phase 4
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female 6 to 11 years of age.
- Females who reached menarche either before or during the study, agreed to use acceptable methods of birth control if they became sexually active. Acceptable birth control was defined as oral contraceptives or Norplant®.
- Outpatient.
- History and diagnosis of seasonal allergic rhinitis (SAR) to a prevalent allergen (grass or tree).
- SAR to a prevalent allergen (grass or tree) of such severity that it required pharmacologic therapy each year for the last 2 consecutive years (including the present year).
- Documented SAR to a prevalent allergen (grass or tree) as confirmed by a recognized skin test (prick, intradermal [ID], or Multitest®) within the previous 15 months (Prick/Puncture wheal® ≥3 mm over the negative control; ID [up to concentration of 1:1000 w/v or 1000 protein nitrogen units (PNU)] wheal® ≥5 mm over the negative control). Documentation of SAR must have occurred at Visit 1 or within 15 months prior to Visit 1. If not performed at Visit 1, SAR testing must have been performed in the Principal Investigator's office or full documentation must have been available prior to randomization.
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- Diary-recorded rhinoconjunctivitis symptom scores (24 hour reflective) that included at least two symptoms (sneezing, runny nose, itchy eyes, or watery eyes) at moderate severity (i.e., symptom score ≥2) on at least 4 days between Visits 1 and 2.
- Diary-recorded TSSC score ≥5 (based on the four symptoms noted in the criteria above) on any 4 days between Visits 1 and 2.
- Someone (subject and parent/legal guardian) from whom the Principal Investigator or study personnel would have expected conscientious cooperation over the duration of the study.
- A written informed assent must have been provided by the subject and a written informed consent must have been provided by the parent/legal guardian at Visit 1.
Who cannot join
- Had clinically significant nasal anatomical deformities with > 50% obstruction (i.e., septal defects, polyps).
- Experienced an episode of acute sinusitis or an upper respiratory tract infection (URTI) including otitis media and the common cold) within 21 days of Visit 1.
- Had a history of chronic sinusitis.
- Initiated or advanced an immunotherapy regimen during the course of the study. Subjects receiving a maintenance dose of immunotherapy were eligible.
- Had a history of attention deficit/hyperactivity disorder (ADHD) that was considered unstable by the Investigator, or if pharmacotherapy (i.e., Ritalin®, Adderall®) was required, subject must have been on pharmacotherapy for at least 1 month prior to Visit 1. The pharmacotherapeutic regimen was to remain stable during the conduct of the study.
- Had a history of learning disabilities or intellectual impairment that, in the opinion of the Investigator, would prevent the subject from participating in the study.
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- Had impaired hepatic function (cirrhosis, hepatitis), glaucoma, or any symptomatic infection, any clinically significant hematologic, renal, endocrine, or gastrointestinal disease, and/or current neuropsychiatric condition with or without drug therapy, that was judged by the Investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial.
- Had a history of malignancy (except basal cell carcinoma), epilepsy or seizures (excluding febrile seizures), excessive alcohol intake or drug addiction, hypertension, or other clinically significant cardiovascular disease.
- Had a physical examination abnormality considered by the Investigator to be clinically significant and limiting to the study's conduct, unless the abnormality was related to underlying allergic rhinitis.
- Had a history of an allergy or hypersensitivity to cetirizine, loratadine, hydroxyzine, or any of their ingredients.
- Had asthma, which required any of the following within the past 30 days: 1) admission to the hospital, 2) emergency room visit, or 3) a change in dosing regimen. Subjects were allowed to continue theophylline, long acting β2 agonists, inhaled cromoglycate no more than 6.4 mg/day, or nedocrimil no more than 14 mg/day. Subjects were allowed to continue inhaled corticosteroids in doses not exceeding those listed in Appendix B of the study protocol, as long as the dose did not change during the study. Subjects were allowed the use of short acting β2 agonists on an as needed (PRN) basis.
- Had used intranasal or intra ophthalmic corticosteroids; oral leukotriene modifiers or leukotriene receptor antagonists within 14 days; or systemic (intramuscular and/or intravenous and/or oral) corticosteroids within 35 days prior to Visit 2. Topical corticosteroids for skin were allowed if covering ≤10% of body surface without occlusion.
- Used intranasal cromolyn (Nasalcrom®), optical cromolyn (Crolom®), ipratropium bromide (Atrovent® Nasal Spray), azelastine hydrochloride (Astelin® Nasal Spray), monamine oxidase (MAO) inhibitors, or beta blockers for the treatment of migraine headaches within 14 days prior to Visit 2.
- Used antiallergic ophthalmic treatments such as Acular®, Patanol®, or Alomide® within 7 days prior to Visit 2.
- Used H1-receptor antagonists (oral and topical), H2-receptor antagonists, or decongestants after Visit 1.
- Used tricyclic antidepressants, tranquilizers, or antiemetics of the phenothiazine class within 14 days prior to Visit 2.
- Used oral macrolide antibiotics or oral antifungals within 7 days prior to Visit 2.
- Used saline nasal spray or ocular drops (unless for contact lens use) within 72 hours prior to Visit 2.
- Participated in any other studies involving investigational or marketed products within 30 days prior to entry into the study or participated in studies which involved norastemizole, or monoclonal anti-immunoglobulin E (IgE) antibody within 90 days prior to entry into the study.
- Donated blood or blood products for transfusion within 30 days prior to initiation of treatment with study drug and at any time during the study.
About this study
Official title: Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-Center Study of the Efficacy and Safety of Zyrtec® (Cetirizine HCl) Syrup vs. Claritin® (Loratadine) Syrup vs. Placebo in Treatment of Children With Seasonal Allergic Rhinitis (SAR)
The objective of this clinical trial was to assess the efficacy and safety of cetirizine HCl syrup vs. loratadine syrup vs. placebo syrup in the treatment of SAR in children 6 to 11 years old.
Read the detailed description
This was a multi-center, randomized, double-blind, parallel-group, placebo-controlled, double dummy study of children with SAR conducted during the Spring tree and grass allergy season. Subjects qualified for randomization if the diary cards included (1) symptom scores of ≥2 for at least 2 of the following 4 rhinoconjunctivitis symptoms on 4 or more days: sneezing, runny nose, itchy eyes, and watery eyes; and (2) a total rhinoconjunctivitis (or Total Symptom Severity Complex [TSSC]) score of ≥5 on any 4 days. The TSSC score was expressed as the sum of the 4 individual symptoms scores recorded in the daily diary cards for the following symptoms: sneezing, runny nose, itchy eyes, and watery eyes.
Subjects were randomized to receive 1 of 3 treatments in a double-blind fashion using a 1:1:1 allocation ratio: cetirizine HCl syrup and placebo loratadine syrup; loratadine syrup and placebo cetirizine HCl syrup; or cetirizine placebo syrup and loratadine placebo syrup.
Number of Subjects (Planned and Analyzed): 1100 planned; 1536 screened; 683 randomized: 231 (33.8%) randomized to the cetirizine HCl treatment group, 221 (32.4%) to the loratadine treatment group, and 231 (33.8%) to the placebo treatment group.
Test Product and Reference Therapy: Subjects randomized to receive cetirizine HCl syrup also received placebo syrup; subjects randomized to receive loratadine syrup also received placebo syrup; and both placebo syrups were received by subjects randomized to receive placebo.
Duration of Double-Blind Treatment: 2 weeks.
Safety measures included the incidence and severity of treatment-emergent adverse events (AEs), vital signs, concomitant medications, and physical examination findings. Clinical laboratory evaluation was not required for this study.
Statistical Methods: All statistical tests related to treatment effect were 2-sided, and statistical significance was declared at the 0.05 probability level. Least squares means (LSMeans) were used to estimate treatment effect. Populations analyzed included the Full Analysis (intent-to-treat [ITT]) Set (FAS), Per-Protocol Set (PPS), Safety-Analyzable Set, and All-Screened Analysis Set. Demographic and baseline data for all subjects in the Safety-Analyzable Set were summarized and listed. The effects of treatment at the Overall and all other analysis Time Points were assessed using ANCOVA models. The main effects model contained terms for treatment and Investigator site, with baseline TSSC value as a covariate. The LSMeans and standard errors were based on the main effects model. Methods of analysis of secondary efficacy data included analysis of covariance (ANCOVA) models and Cochran-Mantel-Haenszel (CMH) row mean scores tests. Analysis of drug safety included the incidence of treatment-emergent AEs (TEAE), concomitant medications, vital signs, and physical examination findings for the Safety-Analyzable Set.
- Conditions
- Allergic Rhinitis, Hay Fever, SAR, Rhinitis, Allergic, Seasonal
- Being tested
- Cetirizine, Loratadine, Placebo
- Keywords
- SAR, seasonal allergic rhinitis, hay fever, seasonal allergic rhinoconjunctivitis
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetirizineDrug
Also called ZYRTEC
Cetirizine HCl 10 mg (1 mg/ml) syrup once daily before 10:00 AM for 2 weeks
LoratadineDrug
Also called CLARITIN
Loratadine HCl 10 mg (1 mg/ml) syrup once daily before 10:00 AM for 2 weeks
PlaceboOther
Placebo syrup once daily before 10:00 AM for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cetirizine 10 mg | Experimental | Cetirizine HCl 10 mg (1 mg/ml) syrup once daily for 2 weeks. Subjects who were randomized to receive cetirizine HCl syrup also received placebo syrup. Each subject was instructed to take 2 teaspoons from Bottle A and 2 teaspoons from Bottle B once daily, before 10:00 AM. Receives: Drug: Cetirizine |
| loratadine 10 mg | Active comparator | Loratadine 10 mg (1 mg/ml) syrup once daily for 2 weeks. Subjects who were randomized to receive loratadine syrup also received placebo syrup. Each subject was instructed to take 2 teaspoons from Bottle A and 2 teaspoons from Bottle B once daily, before 10:00 AM. Receives: Drug: Loratadine |
| placebo | Placebo comparator | Placebo syrup once daily for 2 weeks. Both placebo syrups were received by subjects who were randomized to receive placebo. Each subject was instructed to take 2 teaspoons from Bottle A and 2 teaspoons from Bottle B once daily, before 10:00 AM. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to the Overall endpoint in the subject 24-hour reflective total symptom severity complex (TSSC) score
Measured: 2 weeks
Secondary outcomes (8)
Change from baseline to the Overall endpoint in the subject 24-hour reflective TSSC, with and without stuffy nose score
Subject rated reflective TSSC on 5-point scale
Measured: 2 weeks
Change from baseline to the Overall endpoint in the individual rhinoconjunctivitis symptoms (reflective and instantaneous)
Subject rated individual symptom severity on 5-point scale (reflective and instantaneous)
Measured: 2 weeks
Investigator evaluation of rhinoconjunctivitis symptoms
Change from baseline to all secondary time points (Week 1 [average of TSSC scores during Week 1 of double-blind treatment], Week 2 [average of TSSC scores during Week 2 of double-blind treatment], and Endpoint [last available post-baseline TSSC score]) in subject 24-hour reflective TSSC.
Measured: 2 weeks
Parent/legal guardian evaluation of subject's rhinoconjunctivitis symptoms
Change from baseline to all secondary time points (Week 1 [average of TSSC scores during Week 1 of double-blind treatment], Week 2 [average of TSSC scores during Week 2 of double-blind treatment], and Endpoint [last available post-baseline TSSC score]) in subject 24-hour reflective TSSC.
Measured: 2 weeks
Investigator Global Evaluations of Efficacy at Visit 4/early termination
Investigator assess the therapeutic regimen's effect on 7-point scale
Measured: 2 weeks
Subject/Parent/Legal Guardian Global Evaluations at Visit 4/early termination
Subject/Parent/Legal Guardian provided global evaluation of treatment on a 5-point scale
Measured: 2 weeks
Parent/Legal Guardian Overall Personal Satisfaction Assessment at Visit 4/early termination
Parent/Legal Guardian provided appraisal of overall personal satisfaction with treatment on a 5-point scale
Measured: 2 weeks
Parental Burden Questionnaire
At Visits 2, 3, and 4/early termination, the parent/legal guardian assessed the social and emotional impact of caring for a child with SAR on a 5-point scale
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startMar 2001
- Primary completionJul 2001
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 683 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Dial Hewlett, MD, Study director, Medical Director; Pfizer, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932774
- Sponsor's protocol ID
- A1431009
- Status last verified
- Apr 2017
- First submitted
- 30 Sep 2016
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-Center Study of the Efficacy and Safety of Zyrtec® (Cetirizine HCl) Syrup vs. Claritin® (Loratadine) Syrup vs. Placebo in Treatment of Children With Seasonal Allergic Rhinitis (SAR)
- ClinicalTrials.gov ID
- NCT02932774
- Acronym / sponsor ID
- A1431009
- Conditions
- Allergic Rhinitis, Hay Fever, SAR, Rhinitis, Allergic, Seasonal
- Keywords
- SAR, seasonal allergic rhinitis, hay fever, seasonal allergic rhinoconjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 683 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Mar 2001
- Primary completion
- Jul 2001 (actual)
- Study completion
- Jul 2001 (actual)
- First posted
- 13 Oct 2016 (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.
The objective of this clinical trial was to assess the efficacy and safety of cetirizine HCl syrup vs. loratadine syrup vs. placebo syrup in the treatment of SAR in children 6 to 11 years old.
Detailed description
This was a multi-center, randomized, double-blind, parallel-group, placebo-controlled, double dummy study of children with SAR conducted during the Spring tree and grass allergy season. Subjects qualified for randomization if the diary cards included (1) symptom scores of ≥2 for at least 2 of the following 4 rhinoconjunctivitis symptoms on 4 or more days: sneezing, runny nose, itchy eyes, and watery eyes; and (2) a total rhinoconjunctivitis (or Total Symptom Severity Complex [TSSC]) score of ≥5 on any 4 days. The TSSC score was expressed as the sum of the 4 individual symptoms scores recorded in the daily diary cards for the following symptoms: sneezing, runny nose, itchy eyes, and watery eyes.
Subjects were randomized to receive 1 of 3 treatments in a double-blind fashion using a 1:1:1 allocation ratio: cetirizine HCl syrup and placebo loratadine syrup; loratadine syrup and placebo cetirizine HCl syrup; or cetirizine placebo syrup and loratadine placebo syrup.
Number of Subjects (Planned and Analyzed): 1100 planned; 1536 screened; 683 randomized: 231 (33.8%) randomized to the cetirizine HCl treatment group, 221 (32.4%) to the loratadine treatment group, and 231 (33.8%) to the placebo treatment group.
Test Product and Reference Therapy: Subjects randomized to receive cetirizine HCl syrup also received placebo syrup; subjects randomized to receive loratadine syrup also received placebo syrup; and both placebo syrups were received by subjects randomized to receive placebo.
Duration of Double-Blind Treatment: 2 weeks.
Safety measures included the incidence and severity of treatment-emergent adverse events (AEs), vital signs, concomitant medications, and physical examination findings. Clinical laboratory evaluation was not required for this study.
Statistical Methods: All statistical tests related to treatment effect were 2-sided, and statistical significance was declared at the 0.05 probability level. Least squares means (LSMeans) were used to estimate treatment effect. Populations analyzed included the Full Analysis (intent-to-treat [ITT]) Set (FAS), Per-Protocol Set (PPS), Safety-Analyzable Set, and All-Screened Analysis Set. Demographic and baseline data for all subjects in the Safety-Analyzable Set were summarized and listed. The effects of treatment at the Overall and all other analysis Time Points were assessed using ANCOVA models. The main effects model contained terms for treatment and Investigator site, with baseline TSSC value as a covariate. The LSMeans and standard errors were based on the main effects model. Methods of analysis of secondary efficacy data included analysis of covariance (ANCOVA) models and Cochran-Mantel-Haenszel (CMH) row mean scores tests. Analysis of drug safety included the incidence of treatment-emergent AEs (TEAE), concomitant medications, vital signs, and physical examination findings for the Safety-Analyzable Set.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cetirizine 10 mg | Experimental | Drug: CetirizineCetirizine HCl 10 mg (1 mg/ml) syrup once daily for 2 weeks. Subjects who were randomized to receive cetirizine HCl syrup also received placebo syrup. Each subject was instructed to take 2 teaspoons from Bottle A and 2 teaspoons from Bottle B once daily, before 10:00 AM. |
| loratadine 10 mg | Active comparator | Drug: LoratadineLoratadine 10 mg (1 mg/ml) syrup once daily for 2 weeks. Subjects who were randomized to receive loratadine syrup also received placebo syrup. Each subject was instructed to take 2 teaspoons from Bottle A and 2 teaspoons from Bottle B once daily, before 10:00 AM. |
| placebo | Placebo comparator | Other: PlaceboPlacebo syrup once daily for 2 weeks. Both placebo syrups were received by subjects who were randomized to receive placebo. Each subject was instructed to take 2 teaspoons from Bottle A and 2 teaspoons from Bottle B once daily, before 10:00 AM. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Male or female 6 to 11 years of age.
- Females who reached menarche either before or during the study, agreed to use acceptable methods of birth control if they became sexually active. Acceptable birth control was defined as oral contraceptives or Norplant®.
- Outpatient.
- History and diagnosis of seasonal allergic rhinitis (SAR) to a prevalent allergen (grass or tree).
- SAR to a prevalent allergen (grass or tree) of such severity that it required pharmacologic therapy each year for the last 2 consecutive years (including the present year).
Key exclusion criteria (20 listed)
- Had clinically significant nasal anatomical deformities with > 50% obstruction (i.e., septal defects, polyps).
- Experienced an episode of acute sinusitis or an upper respiratory tract infection (URTI) including otitis media and the common cold) within 21 days of Visit 1.
- Had a history of chronic sinusitis.
- Initiated or advanced an immunotherapy regimen during the course of the study. Subjects receiving a maintenance dose of immunotherapy were eligible.
- Had a history of attention deficit/hyperactivity disorder (ADHD) that was considered unstable by the Investigator, or if pharmacotherapy (i.e., Ritalin®, Adderall®) was required, subject must have been on pharmacotherapy for at least 1 month prior to Visit 1. The pharmacotherapeutic regimen was to remain stable during the conduct of the study.
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 |
|---|---|---|
| CetirizineAlso: ZYRTECCetirizine HCl 10 mg (1 mg/ml) syrup once daily before 10:00 AM for 2 weeks | Drug | Cetirizine 10 mg |
| LoratadineAlso: CLARITINLoratadine HCl 10 mg (1 mg/ml) syrup once daily before 10:00 AM for 2 weeks | Drug | loratadine 10 mg |
| PlaceboPlacebo syrup once daily before 10:00 AM for 2 weeks | Other | placebo |
Primary outcome
Change from baseline to the Overall endpoint in the subject 24-hour reflective total symptom severity complex (TSSC) score
Time frame: 2 weeks
8 secondary outcomes
Change from baseline to the Overall endpoint in the subject 24-hour reflective TSSC, with and without stuffy nose score
Time frame: 2 weeks
Change from baseline to the Overall endpoint in the individual rhinoconjunctivitis symptoms (reflective and instantaneous)
Time frame: 2 weeks
Investigator evaluation of rhinoconjunctivitis symptoms
Time frame: 2 weeks
Parent/legal guardian evaluation of subject's rhinoconjunctivitis symptoms
Time frame: 2 weeks
Investigator Global Evaluations of Efficacy at Visit 4/early termination
Time frame: 2 weeks
Subject/Parent/Legal Guardian Global Evaluations at Visit 4/early termination
Time frame: 2 weeks
Parent/Legal Guardian Overall Personal Satisfaction Assessment at Visit 4/early termination
Time frame: 2 weeks
Parental Burden Questionnaire
Time frame: 2 weeks
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 20 Apr 2017.
- Individual participant dataSharing planned: Yes
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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.
Dial Hewlett, MD study director
Medical Director; Pfizer, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cetirizine and Loratadine in people with Allergic Rhinitis and Hay Fever, run by Johnson & Johnson Consumer and Personal Products Worldwide.
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 10 inclusion and 20 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 20 Apr 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from baseline to the Overall endpoint in the subject 24-hour reflective total symptom severity complex (TSSC) score (time frame: 2 weeks). 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 20 Apr 2017.