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NCT01588535 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Pain and Otitis Media, sponsored by Arbor Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
38
Enrollment target
15
Study locations

NCT01588535: Completed Phase 2 study of Pain and Otitis Media, sponsored by Arbor Pharmaceuticals.

NCT01588535 is a Phase 2 study of Pain and Otitis Media that has completed, run by Arbor Pharmaceuticals. The registered enrollment target is 38 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (87% lower). The trial reports 15 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01588535, a Phase 2 study of Pain and Otitis Media, has completed, sponsored by Arbor Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
38 participants
Enrollment target
15
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • DRUG placebo
  • DRUG benzocaine

Study Locations (15)

Texas

  • DiscoveReseach, Inc. - Bryan
  • Research Across America - Carrollton
  • Research Across America - Dallas
  • Dm Clinical Research - Tomball

Utah

  • Foothill Family Clinic - Salt Lake City
  • FIRSTMED - Salt Lake City
  • Jordon River Family Medicine - South Jordan

Arkansas

  • Nda Baptist Clinic - Jonesboro

Florida

  • COMMUNITY Medical Research - Miami Beach

Iowa

  • The Iowa Clinic, Pc - West Des Moines

Kentucky

  • Kentucky Pediatric/Adult Research - Bardstown

Nebraska

  • Prairie Fields Family Medicine/Clinical Research Advantage - Fremont

Nevada

  • Clinical Research Center - Las Vegas

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2012-05
Est. Completion 2012-08
Phase Phase 2
Arbor Pharmaceuticals

14 total trials

What the finished NCT01588535 record still lists

NCT01588535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (87% lower).

The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT01588535 lists 15 locations in 10 states (Texas, Utah, Arkansas).

Frequently Asked Questions

What is clinical trial NCT01588535 about?

NCT01588535 is a clinical study titled "Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media". 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.

What is the current status of trial NCT01588535?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2012-05. Estimated completion is 2012-08.

What conditions does trial NCT01588535 study?

This clinical trial studies the following conditions: Pain, Otitis Media.

What interventions are being tested in trial NCT01588535?

The interventions under investigation include: placebo (DRUG), benzocaine (DRUG).

Who is sponsoring clinical trial NCT01588535?

This trial is sponsored by Arbor Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01588535 being conducted?

This trial has 15 study locations across Arkansas, Florida, Iowa, Kentucky, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01588535's enrollment target sits among peer trials

38 293rd of 374 higher than 81 of 374 other Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01588535, the US trial registry maintained by the National Library of Medicine. NCT01588535 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.