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NCT01356225 · ClinicalTrials.gov registry record · Phase 2

A Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery

A Phase 2 study of Pain and Dental Impaction, sponsored by Egalet.

Completed
Registry status
Phase 2
Development phase
80
Enrollment target
1
Study location

NCT01356225: Completed Phase 2 study of Pain and Dental Impaction, sponsored by Egalet.

NCT01356225 is a Phase 2 study of Pain and Dental Impaction that has completed, run by Egalet. The registered enrollment target is 80 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01356225, a Phase 2 study of Pain and Dental Impaction, has completed, sponsored by Egalet.

COMPLETED
Registry status
Phase 2
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate the analgesic efficacy of a single intranasal (IN) administration of ketorolac after dental impaction surgery.

Primary Outcome

Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. The PI values were obtained at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours following the first dose of study medication on Day 1. Pain intensity difference (PID) was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. A summed PID

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Ketorolac tromethamine

Study Locations (1)

Texas

  • Austin Oral Surgery - PPD Development - Austin

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2004-02
Phase Phase 2
Egalet

5 total trials

What the finished NCT01356225 record still lists

NCT01356225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (74% 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.

NCT01356225 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT01356225 about?

NCT01356225 is a clinical study titled "A Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery". The purpose of this study is to evaluate the analgesic efficacy of a single intranasal (IN) administration of ketorolac after dental impaction surgery.

What is the current status of trial NCT01356225?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2004-02.

What conditions does trial NCT01356225 study?

This clinical trial studies the following conditions: Pain, Dental Impaction.

What interventions are being tested in trial NCT01356225?

The interventions under investigation include: Placebo (DRUG), Ketorolac tromethamine (DRUG).

Who is sponsoring clinical trial NCT01356225?

This trial is sponsored by Egalet, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01356225 being conducted?

This trial has 1 study location across Texas. 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 NCT01356225's enrollment target sits among peer trials

80 193rd of 374 higher than 171 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 NCT01356225, the US trial registry maintained by the National Library of Medicine. NCT01356225 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.