PainPhase 3NCT02102516
SPRIX in 0 to 11 Year-Old Patients Undergoing Open Surgical Procedures
A Phase 3 study testing SPRIX(intranasal ketorolac tromethamine) in people with Pain, run by Egalet Ltd at 4 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 11 years
- Conditions the study is for
- Pain
- What is being tested?
- SPRIX(intranasal ketorolac tromethamine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesPoland
- Study dates
- Mar 2014to Jul 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Poland4 sites
Instytut "Centrum Zdrowia Matki Polki" (Institute "Mother's Memorial Hospital")
Lodz
Klinika Chirurgii i Traumatologii Dzieciecej - Dzieciecy Szpital Kliniczny im. prof. Antoniego Gebali
Lublin
Regional Hospital of Ludwika Rydygiera in Torun
Torun
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu - Independent Public Clinical Hospital No. 1 in Wroclaw
Wroclaw
About this study
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
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.
Read the detailed description
Evaluate the pharmacokinetics and safety of postoperative administration of SPRIX in pediatric patients (ages 0-11) undergoing open surgical procedures.
- Conditions
- Pain
- Being tested
- SPRIX(intranasal ketorolac tromethamine)
- Keywords
- Post operative pain management
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPRIX(intranasal ketorolac tromethamine)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| SPRIX(intranasal ketorolac tromethamine) | Experimental | Based on subject weight Receives: Drug: SPRIX(intranasal ketorolac tromethamine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
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.
Measured: 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
Ctrough
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.
Measured: 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
tmax
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egalet Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda M. Mundy, MD, PhD, Study director, American Regent, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102516
- Sponsor's protocol ID
- 1SPR11002
- Status last verified
- Mar 2017
- First submitted
- 31 Mar 2014
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02102516
- Acronym / sponsor ID
- 1SPR11002
- Conditions
- Pain
- Keywords
- Post operative pain management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Egalet LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Evaluate the pharmacokinetics and safety of postoperative administration of SPRIX in pediatric patients (ages 0-11) undergoing open surgical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPRIX(intranasal ketorolac tromethamine) | Experimental | Drug: SPRIX(intranasal ketorolac tromethamine)Based on subject weight |
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | SPRIX(intranasal ketorolac tromethamine) |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda M. Mundy, MD, PhD study director
American Regent, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPRIX(intranasal ketorolac tromethamine) in people with Pain, run by Egalet Ltd at 4 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.