Allergic RhinitisPhase 3NCT01673620
A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Participants With Allergic Rhinitis (MK-0476A-484)
A Phase 3 study testing Montelukast 10 mg/loratadine 10 mg in people with Allergic Rhinitis, run by Organon and Co.
Trial summary
The purpose of this study is to assess the safety and tolerability of montelukast 10 mg/loratadine 10 mg versus placebo in Mexican participants with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Montelukast 10 mg/loratadine 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 4 Jul 2012to 10 Oct 2012
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Not pregnant or breastfeeding and does not plan to become pregnant during the study and the 14-day follow-up period
- Female participants of reproductive potential agree to remain abstinent or use one acceptable method of birth control at least 14 days prior to signing the informed consent until 14 days following the last visit
- History for at least 2 years of seasonal allergic rhinitis symptoms that are known to flare during the local allergy season or a clinical history of at least 2 years of perennial allergic rhinitis symptoms that persist year round
- For participants with seasonal allergic rhinitis: a positive skin-prick test (wheal >= 3 mm greater than saline control) to one of the allergens active during the local allergy season or a positive radioallergosorbent test (RAST [defined as a score >= Class III])
- For participants with perennial allergic rhinitis: a positive skin test (wheal >=3 mm greater than saline control) to one of the relevant perennial allergens or a positive RAST (defined as a score >= Class III)
- Nonsmoker and has been a nonsmoker for at least 1 year prior to study Visit 1 with a smoking history of no more than 10 pack-years (1 pack [20 cigarettes] per day for 10 years)
- Must be in good and stable physical health and mental health
Who cannot join
- Hospitalization or hospitalization within 4 weeks of the first scheduled study visit
- Pregnancy or within <= 8 weeks postpartum or is breast feeding
- Any major surgical procedure within 4 weeks of the first scheduled study vist
- Current or recent past abuser of alcohol or illicit drugs
- Prior participation in a clinical trial of montelukast or loratadine within the 4 weeks prior to the first scheduled study visit
- Requires treatment other than inhaled short-acting β-agonist for asthma
Show all 16Show fewer
- (e.g., inhaled or oral corticosteroid, theophylline, nedocromil, cromolyn, oral or long-acting inhaled β-agonist, leukotriene receptor antagonist, leukotriene synthesis inhibitor) and/or uses more than 8 puffs per day of inhaled short-acting β-agonist
- Presence of an upper respiratory tract infection (URI), sinusitis, infectious rhinitis (with symptoms such as sore throat, fever, thick purulent rhinorrhea), ocular infection, or history of any of these within 4 weeks prior to the first scheduled study visit or any time between study Visits 1 and 2
- Other than asthma, any active, acute, or chronic pulmonary disorder which is documented by history or physical examination
- Rhinitis medicamentosa, or non-allergic rhinitis
- Recent history (within 3 months prior to the first scheduled study visit) of a clinically significant psychiatric disorder
- History of an anaphylactic reaction to or is otherwise hypersensitive to
- montelukast, loratadine, or one of their components
- History or current evidence of any general medical condition, concomitant therapy, lab abnormality or other circumstance that might confound the results of the study or interfere with the patient's participation for the full duration of the study
- History of illness that would require treatment with an excluded medication, could be immediately life threatening (ventricular arrhythmia, diabetes mellitus that is not well controlled), would pose restriction on participation or successful completion of the study, or would pose additional risk to the patient by administering the study drug
- History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety of Combination Montelukast/Loratadine (MK-0476A) in Mexican Patients With Allergic Rhinitis
The purpose of this study is to assess the safety and tolerability of montelukast 10 mg/loratadine 10 mg versus placebo in Mexican participants with allergic rhinitis.
- Conditions
- Allergic Rhinitis
- Being tested
- Montelukast 10 mg/loratadine 10 mg, Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast 10 mg/loratadine 10 mgDrug
Also called MK-0476A
Montelukast 10 mg/loratadine 10 mg tablet administered once daily
PlaceboDrug
Matching placebo tablet administered once daily
| Study group | Role | What they receive |
|---|---|---|
| Montelukast 10 mg/loratadine 10 mg | Experimental | Montelukast 10 mg/loratadine 10 mg combination tablet administered orally once daily for 2 weeks Receives: Drug: Montelukast 10 mg/loratadine 10 mg |
| Placebo | Placebo comparator | Matching placebo tablet administered orally once daily for 2 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing at Least One Adverse Event (AE)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.
Measured: Up to 4 weeks
Number of Participants Discontinuing Study Treatment Due to AEs
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study start4 Jul 2012
- Primary completion10 Oct 2012
- Study completion10 Oct 2012
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.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673620
- Sponsor's protocol ID
- 0476A-484
- Status last verified
- Feb 2022
- First submitted
- 3 Aug 2012
- Last updated
- 4 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety of Combination Montelukast/Loratadine (MK-0476A) in Mexican Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01673620
- Acronym / sponsor ID
- 0476A-484
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2012 (actual)
- Primary completion
- 10 Oct 2012 (actual)
- Study completion
- 10 Oct 2012 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Posted 14 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of montelukast 10 mg/loratadine 10 mg versus placebo in Mexican 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 |
|---|---|---|
| Montelukast 10 mg/loratadine 10 mg | Experimental | Drug: Montelukast 10 mg/loratadine 10 mgMontelukast 10 mg/loratadine 10 mg combination tablet administered orally once daily for 2 weeks |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo tablet administered orally once daily for 2 weeks |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Not pregnant or breastfeeding and does not plan to become pregnant during the study and the 14-day follow-up period
- Female participants of reproductive potential agree to remain abstinent or use one acceptable method of birth control at least 14 days prior to signing the informed consent until 14 days following the last visit
- History for at least 2 years of seasonal allergic rhinitis symptoms that are known to flare during the local allergy season or a clinical history of at least 2 years of perennial allergic rhinitis symptoms that persist year round
- For participants with seasonal allergic rhinitis: a positive skin-prick test (wheal >= 3 mm greater than saline control) to one of the allergens active during the local allergy season or a positive radioallergosorbent test (RAST [defined as a score >= Class III])
- For participants with perennial allergic rhinitis: a positive skin test (wheal >=3 mm greater than saline control) to one of the relevant perennial allergens or a positive RAST (defined as a score >= Class III)
Key exclusion criteria (16 listed)
- Hospitalization or hospitalization within 4 weeks of the first scheduled study visit
- Pregnancy or within <= 8 weeks postpartum or is breast feeding
- Any major surgical procedure within 4 weeks of the first scheduled study vist
- Current or recent past abuser of alcohol or illicit drugs
- Prior participation in a clinical trial of montelukast or loratadine within the 4 weeks prior to the first scheduled study visit
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 |
|---|---|---|
| Montelukast 10 mg/loratadine 10 mgAlso: MK-0476AMontelukast 10 mg/loratadine 10 mg tablet administered once daily | Drug | Montelukast 10 mg/loratadine 10 mg |
| PlaceboMatching placebo tablet administered once daily | Drug | Placebo |
Primary outcome
Number of Participants Experiencing at Least One Adverse Event (AE)
Time frame: Up to 4 weeks
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.
Number of Participants Discontinuing Study Treatment Due to AEs
Time frame: Up to 2 weeks
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Montelukast 10 mg/loratadine 10 mg in people with Allergic Rhinitis, run by Organon and Co.
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 7 inclusion and 16 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 4 Sep 2024. 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 14 Nov 2014). 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?
Number of Participants Experiencing at Least One Adverse Event (AE) (time frame: Up to 4 weeks). The study lists 2 primary outcomes in all. 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 4 Sep 2024.