CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Ketorolac tromethaminedrug
Likely dose
Ketorolac tromethamine 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01365624
NCT01365624Phase 1Completed
CompareCT.gov

A Phase 1 Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects

American Regent, Inc.·interventional·Posted Jun 3, 2011·Updated Feb 6, 2013

In Brief

A Phase 1 clinical trial evaluating Ketorolac tromethamine for Healthy Subjects. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This study had an open-label, single-dose design. All subjects received a single dose of 30 mg of intranasal ketorolac. Blood samples for determination of ketorolac plasma levels were obtained pre-dose and at specified time points over 24 hours post-dose. The primary objective of this trial was to compare the pharmacokinetics of intranasal ketorolac between elderly and nonelderly adult subjects. The secondary objective was to evaluate the safety profile of intranasal ketorolac in elderly subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 3, 2011
Enrollment StartFeb 1, 2008
Primary CompletionApr 1, 2008
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.1 years ago

Interventions

Ketorolac tromethaminedrug

Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)