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SPRIX in 0 to 11 Year-Old Patients Undergoing Open Surgical Procedures

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ClinicalTrials.gov Identifier: NCT02102516
Recruitment Status : Completed
First Posted : April 3, 2014
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Egalet Ltd

Brief Summary:
The purpose of this study is to evaluate the pharmacokinetics and safety of postoperative administration of SPRIX in pediatric patients (ages 0-11) undergoing open surgical procedures.

Condition or disease Intervention/treatment Phase
Pain Drug: SPRIX(intranasal ketorolac tromethamine) Phase 3

Detailed Description:
Evaluate the pharmacokinetics and safety of postoperative administration of SPRIX in pediatric patients (ages 0-11) undergoing open surgical procedures.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Open Label Study of the Safety, Efficacy, and Pharmacokinetics of SPRIX (Intranasal Ketorolac Tromethamine) in 0 to 11 Year-Old Patients Undergoing Open Surgical Procedures
Study Start Date : March 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SPRIX(intranasal ketorolac tromethamine)
Based on subject weight
Drug: SPRIX(intranasal ketorolac tromethamine)

Dose: Subjects weighing 3.0 kg received 3.15 mg (1 spray/1 nostril), subjects weighing 5.1 - 10.0 kg received 5.25 mg (1 spray/1 nostril), subjects weighing 10.1 - 15.4 kg received 10.5 mg (1 spray/1 nostril), subjects weighing 15.5 - 31.7 kg received 15.75 mg (1 spray/1 nostril), and subjects weighing >=31.8 kg received 31.5 mg (1 spray/2 nostrils).

Duration of Treatment: Subjects received a dose of SPRIX every 6 hours from the day of surgery until the morning of post-operative Day 2. Dosing may have resumed after final PK assessment of the morning of post-operative Day 3 until post-operative Day 4. A follow-up phone interview took place 14 days after the final dose of study drug.





Primary Outcome Measures :
  1. Cmax [ Time Frame: Pre-dose, .25, .5, .75, 1, 2, 4, 6 hrs after the 1st dose then prior to each ensuing dose until morning of post-operative Day 2. After a single dose on morning of post-operative Day 2 PK samples will be collected @ 1, 2, 4, 6, 8, 12, & 24 hrs ]
    Blood samples will be collected for PK assessment pre-dose, at .25, .5, .75, 1, 2, and 4 hours after the first dose, at 6 hours immediately before the 2nd dose and before each of the next doses up to the dose to be administered on the morning of post operative Day 2. Blood samples will then be collected for PK assessment at 1, 2, 4, 6, 8, 12, and 24 hours after receiving the morning dose on Day 2.

  2. Ctrough [ Time Frame: Pre-dose, .25, .5, .75, 1, 2, 4, 6 hrs after the 1st dose then prior to each ensuing dose until morning of post-operative Day 2. After a single dose on morning of post-operative Day 2 PK samples will be collected @ 1, 2, 4, 6, 8, 12, & 24 hrs ]
    Blood samples will be collected for PK assessment pre-dose, at .25, .5, .75, 1, 2, and 4 hours after the first dose, at 6 hours immediately before the 2nd dose and before each of the next doses up to the dose to be administered on the morning of post operative Day 2. Blood samples will then be collected for PK assessment at 1, 2, 4, 6, 8, 12, and 24 hours after receiving the morning dose on Day 2.

  3. tmax [ Time Frame: Pre-dose, .25, .5, .75, 1, 2, 4, 6 hrs after the 1st dose then prior to each ensuing dose until morning of post-operative Day 2. After a single dose on morning of post-operative Day 2 PK samples will be collected @ 1, 2, 4, 6, 8, 12, & 24 hrs ]
    Blood samples will be collected for PK assessment pre-dose, at .25, .5, .75, 1, 2, and 4 hours after the first dose, at 6 hours immediately before the 2nd dose and before each of the next doses up to the dose to be administered on the morning of post operative Day 2. Blood samples will then be collected for PK assessment at 1, 2, 4, 6, 8, 12, and 24 hours after receiving the morning dose on Day 2.



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Ages Eligible for Study:   up to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients ages 0 to 11 years.
  • Undergoing an open surgical procedure expected to result in at least moderate pain based on an age appropriate scale.
  • Body mass index (BMI) ≤ 95th percentile of 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).
  • With parental assistance, willing and able to complete the study procedures and pain scales and to communicate meaningfully with the study personnel.
  • 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 (although it is anticipated that all 0-11 year old subjects will be pre-menarchal).
  • 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 and his/her parent or guardian is willing and able to sign the informed consent approved by the IRB.

Exclusion Criteria:

  • Surgical procedure performed exclusively by laparoscopy.
  • Known allergy or sensitivity to ketorolac, ethylene diamine tetraacetic acid (EDTA).
  • 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 NSAID's , COX2 inhibitors, tramadol, or acetaminophen at 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 (e.g., 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 Central Nervous System (CNS) active drugs such as benzodiazepines, tricyclic antidepressants, or Selective Serotonin Reuptake Inhibitors (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.
  • History of nasal mucosal damage or active seasonal allergies, nasal congestion or upper respiratory tract infection sufficient to interfere with intranasal drug delivery.
  • Administration of an investigational product within 3 months prior to the first dose of study drug, or scheduled to receive an investigational product, while participating in the study.
  • Use of Toradol (ketorolac tromethamine) in any formulation within the past 30 days prior to study entry and throughout study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102516


Locations
Poland
Instytut "Centrum Zdrowia Matki Polki" (Institute "Mother's Memorial Hospital")
Lodz, Poland
Klinika Chirurgii i Traumatologii Dzieciecej - Dzieciecy Szpital Kliniczny im. prof. Antoniego Gebali
Lublin, Poland
Regional Hospital of Ludwika Rydygiera in Torun
Torun, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu - Independent Public Clinical Hospital No. 1 in Wroclaw
Wroclaw, Poland
Sponsors and Collaborators
Egalet Ltd
Investigators
Study Director: Linda M. Mundy, MD, PhD Luitpold Pharmaceuticals

Responsible Party: Egalet Ltd
ClinicalTrials.gov Identifier: NCT02102516     History of Changes
Other Study ID Numbers: 1SPR11002
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Egalet Ltd:
Post operative pain management

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action