A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Patients With Allergic Rhinitis (MK-0476A-484)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01673620
First received: August 3, 2012
Last updated: November 6, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinitis |
Drug: Montelukast 10 mg/Loratadine 10 mg Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of Participants Experiencing at Least One Adverse Event (AE) [ Time Frame: Up to 2 Weeks ] [ Designated as safety issue: Yes ]
- Number of Participants Discontinuing Study Treatment Due to AEs [ Time Frame: Up to 2 Weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 69 |
| Study Start Date: | July 2012 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Montelukast 10 mg/Loratadine 10 mg
Montelukast 10 mg/loratadine 10 mg once daily.
|
Drug: Montelukast 10 mg/Loratadine 10 mg
Montelukast 10 mg/loratadine 10 mg combination tablet administered orally once daily.
Other Name: MK-0476A
|
|
Placebo Comparator: Placebo
Matching placebo tablet once daily.
|
Drug: Placebo
Matching placebo tablets administered orally once daily.
|
Eligibility| Ages Eligible for Study: | 15 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 (e.g., inhaled or oral corticosteroid, theophylline, nedocromil, cromolyn, oral or longacting 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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01673620 History of Changes |
| Other Study ID Numbers: | 0476A-484 |
| Study First Received: | August 3, 2012 |
| Last Updated: | November 6, 2012 |
| Health Authority: | Mexico: Ministry of Health |
Additional relevant MeSH terms:
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Loratadine Montelukast Antipruritics Dermatologic Agents Therapeutic Uses Pharmacologic Actions Anti-Allergic Agents |
Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 19, 2013