Postoperative PainPhase 3NCT00266786
Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery
A Phase 3 study testing Intranasal Ketorolac Tromethamine in people with Postoperative Pain, run by Egalet Ltd at 6 sites in 2 countries.
Trial summary
Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Intranasal Ketorolac Tromethamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Dec 2005to Feb 2007
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men or women age 18 through 64 years
- Major abdominal surgery
- Body weight ≥ 100 and ≤ 300 pounds
- Negative serum pregnancy test
- Pain intensity score at least 40 (moderate pain) on 100 mm visual analog scale
- Minimum 48 hour hospital stay and 5 day maximum stay
- Able to provide written informed consent
- Willing and able to comply with all testing requirements of the protocol
Who cannot join
- Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)
- Allergy or significant reaction to opioids
- Allergic reaction to aspirin or other nonsteroidal anti-inflammatory drug (NSAIDs)
- Current upper respiratory tract infection or other respiratory tract condition that could interfere with absorption of the nasal spray or adverse event assessment
- Use of any intranasal product in past 24 hours
- Clinically significant abnormality on screening lab tests
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- History of cocaine use
- Active peptic ulcer disease or significant history of peptic ulcer disease or gastrointestinal bleeding
- Advanced renal impairment or risk for renal failure
- History of other medical problems that could interfere with the study participation
- Pregnancy or breastfeeding
- Participation in another investigational study within past 30 days
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Methodist Hospital
Arcadia, California, 91007
Glendale Adventist Medical Center
Glendale, California, 91206
Memorial Hermann Healthcare System
Houston, Texas, 77024
Houston Perinatal Associates
Houston, Texas, 77054
Clinical Management Services, Inc.
Pasadena, California, 91105
About this study
Official title: A Phase 3, Double-Blind, Randomized Study of the Safety, Tolerability, and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain Following Major Abdominal Surgery
Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile.
Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing.
Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
- Conditions
- Postoperative Pain
- Being tested
- Intranasal Ketorolac Tromethamine, Intranasal Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Ketorolac TromethamineDrug
Intranasal at 30mg
Intranasal PlaceboDrug
Intranasal Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Ketorolac Tromethamine | Experimental | Not described Receives: Drug: Intranasal Ketorolac Tromethamine |
| Intranasal Placebo | Placebo comparator | Not described Receives: Drug: Intranasal Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Summed Pain Intensity Difference (SPID) on Day 1
Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. The PI values were obtained every hour following the first dose of study medication on Day 1. Pain intensity difference (PID) was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. A summed PID (SPID) on the first postoperative day was calculated at 6 hours.
Measured: 6 hours after drug administration
Secondary outcomes (4)
Pain intensity difference scores
Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication.
Measured: Prior to receiving study drug and at 20, 40, and 60 minutes, and 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours after the first dose, then prior to each dose up to 72 hours
Quality of analgesia
Quality of analgesia was assessed on a 5-point categorical scale with 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent.
Measured: Prior to receiving study drug and at 20, 40, and 60 minutes, and 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours after the first dose, then prior to each dose up to 72 hours
Global assessment of pain control
A global evaluation of pain control was conducted once daily at bedtime using a 5-point categorical scale on which 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent.
Measured: 8 hours following first dose of study medication
Morphine sulfate consumption at 24, 48, and 72 hours
Measured: 24, 48, and 72 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egalet Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lincoln Bynum, MD, Study chair, ICON Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266786
- Sponsor's protocol ID
- ROX 2005-01
- Status last verified
- Feb 2017
- First submitted
- 16 Dec 2005
- Last updated
- 8 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Randomized Study of the Safety, Tolerability, and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain Following Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00266786
- Acronym / sponsor ID
- ROX 2005-01
- Conditions
- Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Egalet LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Feb 2007 (actual)
- First posted
- 19 Dec 2005 (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.
Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile.
Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing.
Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Ketorolac Tromethamine | Experimental | Drug: Intranasal Ketorolac Tromethamine |
| Intranasal Placebo | Placebo comparator | Drug: Intranasal Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men or women age 18 through 64 years
- Major abdominal surgery
- Body weight ≥ 100 and ≤ 300 pounds
- Negative serum pregnancy test
- Pain intensity score at least 40 (moderate pain) on 100 mm visual analog scale
Key exclusion criteria (12 listed)
- Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)
- Allergy or significant reaction to opioids
- Allergic reaction to aspirin or other nonsteroidal anti-inflammatory drug (NSAIDs)
- Current upper respiratory tract infection or other respiratory tract condition that could interfere with absorption of the nasal spray or adverse event assessment
- Use of any intranasal product in past 24 hours
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 |
|---|---|---|
| Intranasal Ketorolac TromethamineIntranasal at 30mg | Drug | Intranasal Ketorolac Tromethamine |
| Intranasal PlaceboIntranasal Placebo | Drug | Intranasal Placebo |
Primary outcome
The Summed Pain Intensity Difference (SPID) on Day 1
Time frame: 6 hours after drug administration
Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. The PI values were obtained every hour following the first dose of study medication on Day 1. Pain intensity difference (PID) was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. A summed PID (SPID) on the first postoperative day was calculated at 6 hours.
4 secondary outcomes
Pain intensity difference scores
Time frame: Prior to receiving study drug and at 20, 40, and 60 minutes, and 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours after the first dose, then prior to each dose up to 72 hours
Quality of analgesia
Time frame: Prior to receiving study drug and at 20, 40, and 60 minutes, and 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours after the first dose, then prior to each dose up to 72 hours
Global assessment of pain control
Time frame: 8 hours following first dose of study medication
Morphine sulfate consumption at 24, 48, and 72 hours
Time frame: 24, 48, and 72 hours after drug administration
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 8 Feb 2017.
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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.
Lincoln Bynum, MD study chair
ICON Clinical Research
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intranasal Ketorolac Tromethamine in people with Postoperative Pain, run by Egalet Ltd at 6 sites in 2 countries.
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 8 inclusion and 12 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 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, New Zealand. 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. Some participants in this study may receive a placebo. 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?
The Summed Pain Intensity Difference (SPID) on Day 1 (time frame: 6 hours after drug administration). 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 8 Feb 2017.