Postoperative PainPhase 2NCT01351090
Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine (IN) for Postoperative Pain
A Phase 2 study testing Ketorolac tromethamine in people with Postoperative Pain, run by American Regent, Inc. at 1 site in New Zealand.
Trial summary
This was a randomized, double blind, placebo-controlled study in subjects who have undergone major surgery. Each subject's study participation consisted of a screening visit, a 2-day treatment period, and a follow-up visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ketorolac tromethamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteNew Zealand
- Study dates
- Start not givento Oct 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women, age 18 years or older
- Body weight > or = 100 pounds (45.4 kg) and < or = 300 pounds (136.1 kg)
- Women of childbearing potential must have had a negative serum pregnancy test result prior to entry into the study
- Able to provide written informed consent
- At least moderate pain as determined by a PI score of > or = 40 mm on a 100-mm VAS
- Expected to remain in the hospital for at least 48 hours
- Willing and able to comply with all testing and requirements defined in the protocol
- Willing and able to complete the posttreatment visit
Who cannot join
- Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)
- 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 the absorption of the nasal spray or with the assessment of adverse events
- Use of any IN product within 24 hours prior to study entry
- Clinically significant abnormality on screening laboratory tests
- History of cocaine use resulting in nasal mucosal damage
Show all 13Show fewer
- Active peptic ulcer disease, recent (defined as within 6 months) gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding
- Advanced renal impairment or a risk for renal failure due to volume depletion
- A history of any other clinically significant medical problem, which in the opinion of the investigator would interfere with study participation
- Participation within 30 days of study entry or within 5 times the half-life, whichever is longer, in another investigational drug study
- Allergy or significant reaction to opioids
- Pregnancy or breastfeeding
- Previous participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Double-blind, Randomized Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain
This was a randomized, double blind, placebo-controlled study in subjects who have undergone major surgery. Each subject's study participation consisted of a screening visit, a 2-day treatment period, and a follow-up visit. Following surgery, subjects were randomly assigned to receive intranasally (IN) ketorolac 10 mg, IN ketorolac 30 mg, or placebo when the pain intensity (PI) rating equaled at least 40 on a 100-mm visual analog scale (VAS). Thereafter, subjects received study drug every 8 hours, with the last dose given at 40 hours. For pain not relieved by the study drug, the subjects had access to morphine sulfate (MS) administered via patient controlled analgesia (PCA).
The primary objective was to evaluate the analgesic efficacy of multiple intranasal (IN) doses of ketorolac over 2 days. The secondary objective was to evaluate the safety and tolerability of this dosing regimen.
- Conditions
- Postoperative Pain
- Being tested
- Ketorolac tromethamine, 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.
Ketorolac tromethamineDrug
10 mg Intranasal (2 x 100 uL of a 5% solution)
Ketorolac tromethamineDrug
30 mg Intranasal (2 x 100 uL of a 15% solution)
PlaceboDrug
Intranasal
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac tromethamine (5%) | Experimental | Not described Receives: Drug: Ketorolac tromethamine |
| Ketorolac tromethamine (15%) | Experimental | Not described Receives: Drug: Ketorolac tromethamine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours
Measured: 8-hour intervals from the start of dosing through 24 hours
Secondary outcomes (3)
Total MS Use in Milligrams by PCA From the Start of Dosing Through 48 Hours
Measured: 8-hour intervals from the start of dosing through 48 hours
Total MS Use in Milligrams by PCA From 24 Hours After the Start of Dosing Through 48 Hours
Measured: 8-hour intervals from 24 hours after the start of dosing through 48 hours
Pain Intensity Difference (PID) 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: 6 hours after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lincoln Bynum, MD, Study chair, ICON Development Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351090
- Sponsor's protocol ID
- ROX 2001-03
- Status last verified
- Sep 2012
- First submitted
- 9 May 2011
- Last updated
- 18 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Randomized Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain
- ClinicalTrials.gov ID
- NCT01351090
- Acronym / sponsor ID
- ROX 2001-03
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study completion
- Oct 2007 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Posted 18 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomized, double blind, placebo-controlled study in subjects who have undergone major surgery. Each subject's study participation consisted of a screening visit, a 2-day treatment period, and a follow-up visit. Following surgery, subjects were randomly assigned to receive intranasally (IN) ketorolac 10 mg, IN ketorolac 30 mg, or placebo when the pain intensity (PI) rating equaled at least 40 on a 100-mm visual analog scale (VAS). Thereafter, subjects received study drug every 8 hours, with the last dose given at 40 hours. For pain not relieved by the study drug, the subjects had access to morphine sulfate (MS) administered via patient controlled analgesia (PCA).
The primary objective was to evaluate the analgesic efficacy of multiple intranasal (IN) doses of ketorolac over 2 days. The secondary objective was to evaluate the safety and tolerability of this dosing regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketorolac tromethamine (5%) | Experimental | Drug: Ketorolac tromethamine |
| Ketorolac tromethamine (15%) | Experimental | Drug: Ketorolac tromethamine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women, age 18 years or older
- Body weight > or = 100 pounds (45.4 kg) and < or = 300 pounds (136.1 kg)
- Women of childbearing potential must have had a negative serum pregnancy test result prior to entry into the study
- Able to provide written informed consent
- At least moderate pain as determined by a PI score of > or = 40 mm on a 100-mm VAS
Key exclusion criteria (13 listed)
- Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)
- 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 the absorption of the nasal spray or with the assessment of adverse events
- Use of any IN product within 24 hours prior to study entry
- Clinically significant abnormality on screening laboratory tests
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 |
|---|---|---|
| Ketorolac tromethamine10 mg Intranasal (2 x 100 uL of a 5% solution) | Drug | Ketorolac tromethamine (5%) |
| Ketorolac tromethamine30 mg Intranasal (2 x 100 uL of a 15% solution) | Drug | Ketorolac tromethamine (15%) |
| PlaceboIntranasal | Drug | Placebo |
Primary outcome
Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours
Time frame: 8-hour intervals from the start of dosing through 24 hours
3 secondary outcomes
Total MS Use in Milligrams by PCA From the Start of Dosing Through 48 Hours
Time frame: 8-hour intervals from the start of dosing through 48 hours
Total MS Use in Milligrams by PCA From 24 Hours After the Start of Dosing Through 48 Hours
Time frame: 8-hour intervals from 24 hours after the start of dosing through 48 hours
Pain Intensity Difference (PID) Scores
Time frame: 6 hours after study drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Development Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketorolac tromethamine in people with Postoperative Pain, run by American Regent, Inc. at 1 site in New Zealand.
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 13 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 18 Oct 2012. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours (time frame: 8-hour intervals from the start of dosing through 24 hours). 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 18 Oct 2012; AzTrials last refreshed its copy on 8 Nov 2026.