Allergic RhinitisPhase 3NCT01055756
Clinical Trial Of The Effectiveness Of The Product Cloratadd D (Loratadine + Pseudoephedrine Sulfate) Produced By The Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With Allergic Rhinitis
A Phase 3 study testing Loratadine + Pseudoephedrine sulfate in people with Allergic Rhinitis, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The primary objective of this study is to evaluate the clinical efficacy of the drug Cloratadd D ® (loratadine + pseudoephedrine sulfate - EMS S/A) compared to the drug Claritin D ® (loratadine + pseudoephedrine sulfate - Schering Plough) in patients with allergic rhinitis by quantification of the scores of clinical… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Loratadine + Pseudoephedrine sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Jun 2010
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Accept the Consent Form.
- Age between 18 and 60 years, regardless of sex;
- Agree to return to all evaluations of the study;
- Presenting the allergic symptoms confirmed by physical examination and by laboratory tests (IgE and sensitivity to the mite Dermatophagoides pteronyssinus), which should provide a diagnosis of allergic rhinitis with mild to moderate.
Who cannot join
- Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;
- Made use of other medications that interfere with the regular response of the drug in the 4 weeks preceding the start of the study, such as steroids and antihistamines;
- Be patient with sensitivity loratadine / pseudoephedrine sulfate;
- Have any disease or anatomical abnormality in the upper airways is detrimental to the analysis of data, for example, tumors or septal deviations moderate and severe
- Demonstrate a history of alcohol abuse, drugs or pharmaceuticals.
- Have consumed alcohol within 48 hours prior to the period of hospitalization;
Show all 15Show fewer
- Have a history of liver disease or kidney disease;
- Present framework of current asthma or recent (less than 1 year);
- To present the severe pressure of any cause or be on medication for that;
- Smokers or patients who stopped smoking less than 06 months;
- Pregnant or nursing women;
- Patients with heart disease or who use medication for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers;
- Patients using corticosteroids or other medicines that interact with the study drugs as monoamine oxidase;
- Patients with a history of glaucoma, urinary retention, and hyperthyroidism;
- Patients who have undergone facial plastic surgery that the physician's discretion, will interfere with nasal airflow
Trial locations and contacts
1 site in 1 country.
Brazil1 site
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, 13276245
About this study
The primary objective of this study is to evaluate the clinical efficacy of the drug Cloratadd D ® (loratadine + pseudoephedrine sulfate - EMS S/A) compared to the drug Claritin D ® (loratadine + pseudoephedrine sulfate - Schering Plough) in patients with allergic rhinitis by quantification of the scores of clinical parameters (signs and symptoms) and laboratory (nasal flow) down through time.
Read the detailed description
Secondly, it will be observed safety (tolerability) clinic after the administration of the drug in patients by comparing the clinical parameters and the incidence of adverse events.
- Conditions
- Allergic Rhinitis
- Being tested
- Loratadine + Pseudoephedrine sulfate
- Keywords
- Reduction of signs and symptoms and enhanced nasal flow, Nasal Flow
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loratadine + Pseudoephedrine sulfateDrug
Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg)
| Study group | Role | What they receive |
|---|---|---|
| Test (Cloratadd D) | Experimental | Loratadine + Pseudoephedrine sulfate Test Receives: Drug: Loratadine + Pseudoephedrine sulfate |
| Comparator (Claritin D) | Active comparator | Loratadine + Pseudoephedrine Comparator Receives: Drug: Loratadine + Pseudoephedrine sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical signs and symptoms and nasal flow
Measured: 12 hours.
Secondary outcomes (1)
Avaliation of Safety through the adverse affects observation
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010 (estimated)
- Study completionJun 2010 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055756
- Sponsor's protocol ID
- LOREMS0909
- Other IDs
- Version 3, Amendment 1
- Status last verified
- Oct 2022
- First submitted
- 10 Dec 2009
- Last updated
- 31 Oct 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Of The Effectiveness Of The Product Cloratadd D (Loratadine + Pseudoephedrine Sulfate) Produced By The Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01055756
- Acronym / sponsor ID
- LOREMS0909
- Conditions
- Allergic Rhinitis
- Keywords
- Reduction of signs and symptoms and enhanced nasal flow, Nasal Flow
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 26 Jan 2010 (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 primary objective of this study is to evaluate the clinical efficacy of the drug Cloratadd D ® (loratadine + pseudoephedrine sulfate - EMS S/A) compared to the drug Claritin D ® (loratadine + pseudoephedrine sulfate - Schering Plough) in patients with allergic rhinitis by quantification of the scores of clinical parameters (signs and symptoms) and laboratory (nasal flow) down through time.
Detailed description
Secondly, it will be observed safety (tolerability) clinic after the administration of the drug in patients by comparing the clinical parameters and the incidence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test (Cloratadd D) | Experimental | Drug: Loratadine + Pseudoephedrine sulfateLoratadine + Pseudoephedrine sulfate Test |
| Comparator (Claritin D) | Active comparator | Drug: Loratadine + Pseudoephedrine sulfateLoratadine + Pseudoephedrine Comparator |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Accept the Consent Form.
- Age between 18 and 60 years, regardless of sex;
- Agree to return to all evaluations of the study;
- Presenting the allergic symptoms confirmed by physical examination and by laboratory tests (IgE and sensitivity to the mite Dermatophagoides pteronyssinus), which should provide a diagnosis of allergic rhinitis with mild to moderate.
Key exclusion criteria (15 listed)
- Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;
- Made use of other medications that interfere with the regular response of the drug in the 4 weeks preceding the start of the study, such as steroids and antihistamines;
- Be patient with sensitivity loratadine / pseudoephedrine sulfate;
- Have any disease or anatomical abnormality in the upper airways is detrimental to the analysis of data, for example, tumors or septal deviations moderate and severe
- Demonstrate a history of alcohol abuse, drugs or pharmaceuticals.
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 |
|---|---|---|
| Loratadine + Pseudoephedrine sulfateLoratadine (5 mg) + Pseudoephedrine sulfate (120 mg) | Drug | Comparator (Claritin D), Test (Cloratadd D) |
Primary outcome
Clinical signs and symptoms and nasal flow
Time frame: 12 hours.
1 secondary outcome
Avaliation of Safety through the adverse affects observation
Time frame: 12 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Loratadine + Pseudoephedrine sulfate in people with Allergic Rhinitis, run by Azidus Brasil at 1 site in Brazil.
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 4 inclusion and 15 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: withdrawn, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical signs and symptoms and nasal flow (time frame: 12 hours.). 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 31 Oct 2022.