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Completed Phase 2 Interventional

Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media

ClinicalTrials.gov ID: NCT01588535

Public ClinicalTrials.gov record NCT01588535. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 9:05 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01588535
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Arbor Pharmaceuticals, Inc.
Industry
Enrollment
38 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
2 Months to 4 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2012
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012
Last update posted
May 3, 2015

2012

United States locations

U.S. sites
15
U.S. states
10
U.S. cities
14
Facility City State ZIP Site status
Nda Baptist Clinic Jonesboro Arkansas 72401
COMMUNITY Medical Research Miami Beach Florida 33141
The Iowa Clinic, Pc West Des Moines Iowa 50266
Kentucky Pediatric/Adult Research Bardstown Kentucky 40004
Prairie Fields Family Medicine/Clinical Research Advantage Fremont Nebraska 68025
Clinical Research Center Las Vegas Nevada 89104
Odyssey Research Fargo North Dakota 58104
ACCESS CLINICAL TRIALS, Inc. / Centennial Medical Center Clarksville Tennessee 37203
DiscoveReseach, Inc. Bryan Texas 77082
Research Across America Carrollton Texas 75010
Research Across America Dallas Texas 75234
Dm Clinical Research Tomball Texas 77375
Foothill Family Clinic Salt Lake City Utah 84109
FIRSTMED Salt Lake City Utah 84121
Jordon River Family Medicine South Jordan Utah 84095

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01588535, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 3, 2015 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01588535 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →