PainPhase 3NCT01819610
Pharmacokinetics, Safety, and Efficacy of SPRIX in 12 to 17 Year Old Patients vs. Adult Patients Undergoing Open Surgical Procedures
A Phase 3 study testing SPRIX in people with Pain, run by American Regent, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 64 years
- Conditions the study is for
- Pain
- What is being tested?
- SPRIX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Aug 2014
- 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 12 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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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.
- 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.
Who cannot join
- 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.
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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 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.
- 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
1 site in 1 country.
United States1 site
Luitpold Pharmaceuticals, Inc.
Norristown, Pennsylvania, 19403
About this study
Official title: A Single Arm, Open Label Study to Compare the Pharmacokinetics, Safety, and Efficacy of SPRIX (Intranasal Ketorolac Tromethamine) in 12 to 17 Year Old Patients vs. Adult Patients (18-64 Years) Undergoing Open Surgical Procedures
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.
Read the detailed 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.
- Conditions
- Pain
- Being tested
- SPRIX
- Keywords
- Postoperative 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.
SPRIXDrug
Also called SPRIX (intranasal ketorolac tromethemine)
| Study group | Role | What they receive |
|---|---|---|
| SPRIX | Experimental | Subjects will be administered open label SPRIX according to subject weight. Receives: Drug: SPRIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2014
- Study completionAug 2014
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Bregman, M.D, Ph.D., Study director, American Regent, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819610
- Sponsor's protocol ID
- 1SPR11001
- Status last verified
- Jul 2015
- First submitted
- 25 Feb 2013
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label Study to Compare the Pharmacokinetics, Safety, and Efficacy of SPRIX (Intranasal Ketorolac Tromethamine) in 12 to 17 Year Old Patients vs. Adult Patients (18-64 Years) Undergoing Open Surgical Procedures
- ClinicalTrials.gov ID
- NCT01819610
- Acronym / sponsor ID
- 1SPR11001
- Conditions
- Pain
- Keywords
- Postoperative pain management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 27 Mar 2013 (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.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPRIX | Experimental | Drug: SPRIXSubjects will be administered open label SPRIX according to subject weight. |
Who may qualify
- Ages
- 12 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| SPRIXAlso: SPRIX (intranasal ketorolac tromethemine) | Drug | SPRIX |
Primary outcome
Cmax
Time frame: 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
Time frame: 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
Time frame: 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
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 7 Jul 2015.
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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.
David Bregman, M.D, Ph.D. study director
American Regent, Inc.
1 site 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 in people with Pain, run by American Regent, Inc. at 1 site in United States.
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 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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). 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 7 Jul 2015.