A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
This study has been completed.
Sponsor:
West Penn Allegheny Health System
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
David Skoner, MD, West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT00189462
First received: September 13, 2005
Last updated: October 13, 2014
Last verified: October 2014
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Purpose
The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Otitis Media Otitis Media Ear Infection |
Drug: Montelukast |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by West Penn Allegheny Health System:
Primary Outcome Measures:
- Incidence of Acute Otitis Media [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 99 |
| Study Start Date: | March 2004 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Montelukast
Treatment with montelukast for 4 months (4 mg per day)
|
Drug: Montelukast |
|
Placebo Comparator: Placebo
Treatment with placebo for 4 months
|
Detailed Description:
Otitis media (OM) is one of the most common childhood disorders requiring physician care and has been associated with an alarming rise in prevalence. Certain children are prone to recurrent episodes of acute Otitis media (RAOM) and/or the development of chronic Otitis media with effusion (COME). Because medical therapy with antibiotics, antihistamines, decongestants and corticosteroids has no demonstrable efficacy, the mainstay of treatment is surgical intervention, which is quite expensive and exposes patients to risks of general anesthesia. The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)
Eligibility| Ages Eligible for Study: | 18 Months to 5 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
-
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189462
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189462
Locations
| United States, Pennsylvania | |
| Bellevue Pediatric Associates | |
| Bellevue, Pennsylvania, United States, 15202 | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
Sponsors and Collaborators
West Penn Allegheny Health System
Merck Sharp & Dohme Corp.
Investigators
| Principal Investigator: | David Skoner, MD | West Penn Allegheny Health System |
More Information
| Responsible Party: | David Skoner, MD, Principal Investigator, Director, Asthma & Allergy Dept, West Penn Allegheny Health System |
| ClinicalTrials.gov Identifier: | NCT00189462 History of Changes |
| Other Study ID Numbers: | RC - 3643 |
| Study First Received: | September 13, 2005 |
| Results First Received: | September 23, 2014 |
| Last Updated: | October 13, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by West Penn Allegheny Health System:
|
Ear Infections Otitis Media |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on September 26, 2016