- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01588535
Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media
April 13, 2015 updated by: Arbor Pharmaceuticals, Inc.
Phase 2, Multicenter, Placebo-controlled, Double-masked, Randomized Study to Demonstrate Reliability and Validity of FAECC Scale (Modified FLACC) to Evaluate Relief of Pain in Subjects With Acute Otitis Media Aged >/=2 Months to <5 Years
This study is to assess the reliability and validity of the FAECC scale to evaluate pain associated with acute otitis media in children aged 2 months to 5 years.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
to assess the reliability and validity of the FAECC pain scale tool in children aged 2 months to 5 years with acute otitis media given AR01 or placebo
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Jonesboro, Arkansas, United States, 72401
- Nda Baptist Clinic
-
-
Florida
-
Miami Beach, Florida, United States, 33141
- COMMUNITY Medical Research
-
-
Iowa
-
West Des Moines, Iowa, United States, 50266
- The Iowa Clinic, PC
-
-
Kentucky
-
Bardstown, Kentucky, United States, 40004
- Kentucky Pediatric/Adult Research
-
-
Nebraska
-
Fremont, Nebraska, United States, 68025
- Prairie Fields Family Medicine/Clinical Research Advantage
-
-
Nevada
-
Las Vegas, Nevada, United States, 89104
- Clinical Research Center
-
-
North Dakota
-
Fargo, North Dakota, United States, 58104
- Odyssey Research
-
-
Tennessee
-
Clarksville, Tennessee, United States, 37203
- ACCESS CLINICAL TRIALS, Inc. / Centennial Medical Center
-
-
Texas
-
Bryan, Texas, United States, 77082
- DiscoveReseach, Inc.
-
Carrollton, Texas, United States, 75010
- Research Across America
-
Dallas, Texas, United States, 75234
- Research Across America
-
Tomball, Texas, United States, 77375
- DM Clinical Research
-
-
Utah
-
Salt Lake City, Utah, United States, 84109
- Foothill Family Clinic
-
Salt Lake City, Utah, United States, 84121
- FIRSTMED
-
South Jordan, Utah, United States, 84095
- Jordon River Family Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The patient has age in the interval 2 months ≤ age < 5.00 years, signs and symptoms of AOM, and moderate to severe pain (current episode ≤ 2 weeks duration). Moderate to severe pain is defined as a score of > or = 4 (on a scale of 0 - 10) for the FAECC scale as assessed by the primary assessor.
- The patient's parent/guardian must have read and signed the written informed consent prior to study participation.
- The patient is normally active and otherwise judged to be in good health on the basis of medical history and limited physical examination.
Exclusion Criteria:
- Patient has perforated tympanic membrane, history of a perforated tympanic membrane in the last 6 months, or if a perforated tympanic membrane could not be ruled out by speculum examination, impedance testing tympanometry, pneumatic otoscopy, or Valsalva maneuver. Patients who are subsequently diagnosed with a perforated membrane during treatment are to be discontinued immediately. Patients with tympanostomy tubes are not allowed.
- Patient has acute or chronic otitis externa.
- Patient has chronic otitis media (current episode ≥ 2 weeks).
- Patient has seborrheic dermatitis involving the affected external ear canal or pinna.
- Patient has received any otic topical or systemic antibiotic within 14 days prior to study entry (topical or systemic antibiotics for acne will be allowed on a chronic basis for subjects who have been on a stable dose for at least 14 days prior to entry).
- Patient has received any topical drying agent or over-the-counter therapy for otitis media within 36 hours prior to enrollment.
- Patient has fever ≤ 102.0 F (oral or equivalent).
- Patient has known hypersensitivity to the study drug or similar compounds including any of the inactive ingredients.
- Patient is receiving medication on a chronic basis for pain (including steroidal or non steroidal anti-inflammatory drugs) and has not been on a stable dose for at least 1 month prior to entry into the study.
- Patient has clinically significant mental illness (to be determined by the Investigator).
- Patient has been exposed to any investigational agent within 30 days prior to study entry.
- Patient has been previously enrolled in this study.
- Patient or caregiver (parent/guardian) has a condition the Investigator believes will interfere with the ability to provide consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk.
- Patient has a glucose 6-phosphate dehydrogenase deficiency or is taking concomitant medications associated with methemoglobinemia (such as nitrates or nitrites; aniline dyes; or medications, including lidocaine, prilocaine, phenazopyridine hydrochloride [Pyridium], and others).
- Patient demonstrates clinical signs of anemia. The absolute amount of deoxygenated or abnormal hemoglobin (rather than its percentage) is required for cyanosis to be clinically evident. Patients with moderate-to-severe anemia may not appear cyanotic, even with elevated percentages of deoxygenated or abnormal hemoglobin.
- Patient has congenital (i.e., hereditary) methemoglobinemia.
- Patient has a recent history of acute gastroenteritis within 14 days prior to study entry. An association between methemoglobinemia and acute gastroenteritis in infants has been noted in several studies and may be due to acidosis from stool bicarbonate loss impairing the already immature function of the methemoglobin reductase system in these young patients.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: benzocaine solution
ear drops
|
benzocaine 10 mg/mL, five drops in affected ear canal each hour as needed
Other Names:
|
Placebo Comparator: Placebo
ear drops
|
placebo solution, five drops in affected ear canal each hour as needed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Consistency of primary assessor and caregiver FAECC scores using Pearson's correlation coefficient
Time Frame: up to 120 minutes after first dose and Day 4
|
up to 120 minutes after first dose and Day 4
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
reduction in pain scores from predose to each post-dose time point
Time Frame: up to 120 minutes after each dose
|
up to 120 minutes after each dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Laurence Downey, MD, Arbor Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
April 27, 2012
First Submitted That Met QC Criteria
April 27, 2012
First Posted (Estimate)
May 1, 2012
Study Record Updates
Last Update Posted (Estimate)
May 4, 2015
Last Update Submitted That Met QC Criteria
April 13, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AR01.004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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