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

NCT01819610 | Completed Phase 3 DMC

• 1 other identifier: 1SPR11001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

Postoperative pain management

Outcome Measures

Primary Outcomes (3)

• Cmax

  Pre-dose & .25, .5, .75, 1, 2, 4 hrs after the dose @ 6 hrs & prior to each ensuing dose until morning of post-operative Day 2. After a single dose on the morning of post-operative Day 2 further PK samples will be collected @ 1, 2, 4, 6, 8, 12, & 24 hrs

• Ctrough

  Pre-dose & .25, .5, .75, 1, 2, 4 hrs after the dose @ 6 hrs & prior to each ensuing dose until morning of post-operative Day 2. After a single dose on the morning of post-operative Day 2 further PK samples will be collected @ 1, 2, 4, 6, 8, 12, & 24 hrs

• tmax

  Pre-dose & .25, .5, .75, 1, 2, 4 hrs after the dose @ 6 hrs & prior to each ensuing dose until morning of post-operative Day 2. After a single dose on the morning of post-operative Day 2 further PK samples will be collected @ 1, 2, 4, 6, 8, 12, & 24 hrs

Study Arms (1)

SPRIX

EXPERIMENTAL

Subjects will be administered open label SPRIX according to subject weight.

Drug: SPRIX

Interventions

SPRIX DRUG

Also known as: SPRIX (intranasal ketorolac tromethemine)

SPRIX

Eligibility Criteria

• Age: 12 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male of female patients age 12-64 years.
• Undergoing an open surgical procedure expected to result in at least moderate pain (at least 40 on 0-100 VAS).
• Body mass index (BMI)≤ 95th percentile for age.
• Surgical procedures that would allow the subject to likely remain in the hospital until the morning of post-operative day 3 (to complete PK sample collection).
• Willing and able to complete the study procedures and pain scales and to communicate meaningfully with the study personnel (with parental assistance if pediatric).
• In generally good health and capable of undergoing surgery.
• Females at risk of pregnancy were to use an acceptable form of birth control and have a negative serum or urine pregnancy test.
• Willing to refrain from use of non-study analgesics for the duration of the study, from the day of surgery up to post-operative day 4.
• Assents to participation (if pediatric) and his/her parent or guardian is willing and able to sign the informed consent approved by the IRB. Consents to participation and willing and able to sign the informed consent approved by the IRB if adult.

You may not qualify if:

• Surgical procedure performed exclusively by laparoscopy.
• Known allergy or sensitivity to ketorolac, ethylene diamine tetraacetic acid (EDTA), or any nonsteroidal anti-inflammatory drug (NSAID).
• Prior nasal-septal injury or surgery.
• History of peptic ulcer, gastro-esophageal reflux, or gastrointestinal bleeding.
• History of advanced renal impairment or a risk for renal failure due to volume depletion.
• Clinically significant (in the Investigator's opinion) laboratory test value outside the normal range.
• Use of either (a) oxycodone at a dose of 30 mg/day or more or (b) an equivalent dose of another opioid analgesic for a total of more than half of the days during the preceding month.
• The patient requires regular use (daily use in at least 25 days per month) in the 3 months prior to surgery of NSAIDs, COX2 inhibitors, tramadol, or acetaminophen at a daily dose of more than 2 g for the management of pain.
• Contraindication to the use of morphine, general anesthetics, bupivacaine, ropivacaine, lidocaine, other local anesthetics, muscle relaxants, hydrocodone, ondansetron, or acetaminophen (eg, significant history of allergic reactions or intolerance to these or related substances).
• Known bleeding diathesis or other disorder or current use of agents affecting coagulation. Deep venous thrombosis prophylaxis of the surgeon's choice is permitted postoperatively.
• Current use of CNS active drugs such as benzodiazepines, tricyclic antidepressants, or SSRIs for pain. These drugs are permitted for non-pain indications if the dose has been stable for at least 30 days. The use of lorazepam and other sleep medications, except those containing analgesic properties, are permitted.
• Current diabetes mellitus and HbA1C \> 9.5 or a history of prolonged uncontrolled diabetes.
• Use of an antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days.
• Any medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including active infection.
• History of drug, prescription medicine, or alcohol abuse that would interfere with the subject's safety or the assessments of efficacy in this trial, in the judgement of the investigator.

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

Luitpold Pharmaceuticals, Inc.

Norristown, Pennsylvania, 19403, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Bregman, M.D, Ph.D.

  American Regent, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: March 27, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 7, 2015

Record last verified: 2015-07

Locations

US (1)