A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
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ClinicalTrials.gov Identifier: NCT00189462 |
Recruitment Status :
Completed
First Posted : September 19, 2005
Results First Posted : October 8, 2014
Last Update Posted : November 18, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Otitis Media Otitis Media Ear Infection | Drug: Montelukast Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 99 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children |
Study Start Date : | March 2004 |
Actual Primary Completion Date : | December 2005 |
Actual Study Completion Date : | December 2005 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Montelukast
Treatment with montelukast for 4 months (4 mg per day)
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Drug: Montelukast |
Placebo Comparator: Placebo
Treatment with placebo for 4 months
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Drug: Placebo |
- Incidence of Acute Otitis Media [ Time Frame: 16 weeks ]

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Ages Eligible for Study: | 18 Months to 5 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aged 18 months to 5 years old.
- Diagnosis of current AOM
Exclusion Criteria:
- Presence of primary or secondary immunodeficiency, craniofacial abnormality, cleft palate, anatomic predisposition, major congenital anomaly or syndrome, or severe systemic disease
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Use of:
- Any investigational medications within the past 30 days, systemic or oral or nasal steroids within the past 30 days
- Accolate® in the past 7 days
- Antibiotics within the past week, except for Zithromax®, which will be 21 days
- Long acting second generation antihistamines (i.e., Claritin®, Clarinex®, Allegra® and Zyrtec®) within the past 72 hours.
- No known allergy to either montelukast or amoxicillin/clavulanate
- Have not responded to Augmentin® in the past

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189462
United States, Pennsylvania | |
Bellevue Pediatric Associates | |
Bellevue, Pennsylvania, United States, 15202 | |
Allegheny General Hospital | |
Pittsburgh, Pennsylvania, United States, 15212 |
Principal Investigator: | David Skoner, MD | West Penn Allegheny Health System |
Responsible Party: | Deborah Gentile, Co- Investigator, Asthma & Allergy Dept, West Penn Allegheny Health System |
ClinicalTrials.gov Identifier: | NCT00189462 |
Other Study ID Numbers: |
RC - 3643 |
First Posted: | September 19, 2005 Key Record Dates |
Results First Posted: | October 8, 2014 |
Last Update Posted: | November 18, 2020 |
Last Verified: | October 2020 |
Ear Infections Otitis Media |
Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases Montelukast Anti-Asthmatic Agents Respiratory System Agents |
Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP1A2 Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action |