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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01673620
First received: August 3, 2012
Last updated: November 6, 2012
Last verified: November 2012
  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 Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
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 July 26, 2014