Pain Clinical Trial - Pharmacokinetics, Safety, & Efficacy of SPRIX in 12

Status Completed

Clinical Trial Summary

A SPRIX trial in pediatric subjects vs. adults undergoing open surgical procedures resulting in at least a moderate pain level. Subjects will receive SPRIX and blood samples will be collected for pharmacokinetic (PK) assessment. Subjects will also be assessed on the safety and efficacy of SPRIX.

Clinical Trial Description

This is a study of intranasal (IN) ketorolac tromethamine (SPRIX) in pediatric subjects age 12-17 years vs. adults ages 18-64 years undergoing open surgical procedures that are expected to result in at least a moderate level of pain (i.e., 40 or above on a 0-100 Visual Analog Scale (VAS) in which 0 is no pain and 100 is the worst pain imaginable). Following surgery subjects will receive their 1st dose of SPRIX, if and when pain reaches a VAS of 40 or more, followed by SPRIX administration every 6 hours. Blood samples for PK assessment will then be collected for PK assessment pre-dose, at 0.25, 0.5, 0.75, 1, 2, and 4 hours after the first dose, at 6 hours (immediately before the 2nd dose), and immediately before each of the next several subsequent q6h doses up to the dose to be administered on the morning of post-operative day 2. Blood samples will then be collected at 1, 2, 4, 6, 8, 12, and 24 hours after receiving the morning dose on day 2 (i.e., last blood sample for PK will be collected on the morning of post-operative day 3). Pain intensity (PI) will be assessed using the 0-100 VAS at 0.5, 1, 2, 4, and 6 hours post dose, at 2 hours after the 2nd dose, and then immediately prior to each dose at 12, 18, and 24 hours from baseline. Patients may elect to continue taking SPRIX for a total of 5 days with daily assessments of pain intensity using a diary. A final follow-up phone interview will be conducted 14 days after the final dose of study drug. Thus, each subject's study participation will consist of a screening visit, a treatment/assessment period of up to 5 days, and a follow-up interview. ;

Study Design

Related Conditions & MeSH terms

Pain

Clinical Trial Details

NCT number	NCT01819610
Study type	Interventional
Source	Luitpold Pharmaceuticals
Contact
Status	Completed
Phase	Phase 3
Start date	February 2013
Completion date	August 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pharmacokinetics, Safety, and Efficacy of SPRIX in 12 to 17 Year Old Patients vs. Adult Patients Undergoing Open Surgical Procedures

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms