PainPhase 2NCT01356225
A Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery
A Phase 2 study testing Ketorolac tromethamine in people with Pain and Dental Impaction, run by Egalet Ltd at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the analgesic efficacy of a single intranasal (IN) administration of ketorolac after dental impaction surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Dental Impaction
- What is being tested?
- Ketorolac tromethamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Mar 2004
- Phase
- Phase 2
- 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 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 = to 100 pounds and < or = 300 pounds.
- Women of childbearing potential must have 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 = to 50 mm on a 100-mm VAS.
- Willing and able to comply with all testing and requirements defined in the protocol.
- Willing and able to complete the posttreatment visit.
- Immediately prior to entering the study, surgical removal of 3 or 4 third molars (at least 1 mandibular partial bony or complete bony impaction).
Who cannot join
- Allergy or sensitivity to ketorolac or EDTA.
- Allergic reaction to aspirin or other 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 (AEs).
- 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.
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- Active peptic ulcer disease, recent (defined as within 6 months) history of peptic ulcer disease or gastrointestinal bleeding considered by the investigator to be clinically significant.
- Advanced renal impairment (serum creatinine >1.5 mg/dL) 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.
- Pregnancy or breastfeeding.
- Extraction of teeth other than third molars during the surgical procedure; exceptions:(1) supernumerary third molars; (2) cases whereby extraction of a third molar requires the removal of an adjacent molar.
- Previous participation in this study.
- Use of any short-acting NSAID (such as aspirin or ibuprofen) or acetaminophen within 12 hours of surgery.
- Use of longer-acting NSAIDs (such as naproxen sodium) within 48 hours of surgery or piroxicam within 7 days of surgery.
- Use of steroids (other than oral contraceptives) within 72 hours of surgery.
- Use of mood-altering drugs, such a cannabis or alcohol, within 12 hours of surgery.
- Surgical anesthesia including narcotic agents except fentanyl. Short-acting anesthetics, both DEA scheduled and unscheduled, were allowed. Naloxone in any form was not permitted.
- Use of any other medication within 24 hours prior to surgery that, in the opinion of the investigator, could confound the subject's efficacy assessments (eg, sedatives, tranquilizers, MAO inhibitors, phenothiazines).
- Consumption of any caffeine-containing products within 4 hours of surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel, Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery
The purpose of this study is to evaluate the analgesic efficacy of a single intranasal (IN) administration of ketorolac after dental impaction surgery.
- Conditions
- Pain, Dental Impaction
- Being tested
- Ketorolac tromethamine, Placebo
- Keywords
- pain following dental impaction surgery
- Medical subject headings
- Pain, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac tromethamineDrug
30 mg Intranasal (2 x 100 uL of a 15% solution), single dose
PlaceboDrug
IN placebo
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Ketorolac tromethamine | Experimental | Not described Receives: Drug: Ketorolac tromethamine |
| Intranasal 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.
Summed Pain Intensity Difference (SPID)
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 at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours 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 8 hours.
Measured: 8 hours postdose
Secondary outcomes (9)
Summed Pain Intensity Difference (SPID)
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 at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours 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 4 and 6 hours.
Measured: 4 and 6 hours postdose
Total Pain Relief (TOTPAR)
Scores were obtained from the pain relief evaluations by taking a weighted sum of pain relief scores. Pain relief was measured at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours on a 5-point categorical scale where 0 = no pain relief, 1 = a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.
Measured: 4, 6, and 8 hours postdose
Pain intensity difference (PID) and pain relief 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. Pain relief was measured on a 5-point categorical scale with 0 = no pain relief, 1 = a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.
Measured: Before receiving study drug (baseline), at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours postdose
Peak PID score
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. Peak PID was defined as the maximum PID score.
Measured: 4, 6, and 8 hours postdose
Peak pain relief scores
Pain relief was measured on a 5-point categorical scale with 0 = no pain relief, 1 = a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief. Peak pain relief was defined as the maximum peak pain relief score.
Measured: 4, 6, and 8 hours postdose
Time to onset of perceptible pain and meaningful pain relief
The onset of pain relief was measured by the subjects stopping stopwatches when perceptible and meaningful relief was felt.
Measured: After study drug administration until perceptible and meaningful pain relief was felt (during the 8-hour postdose observation period)
Time to first use of rescue medication
Duration of analgesia represented by the time until rescue analgesic therapy was requested.
Measured: After study drug administration until rescue analgesic therapy was requested (during the 8-hour postdose observation period)
Proportion of subjects taking rescue medication
Proportion of subjects taking rescue medication in either group during the 8-hour postdose observation period.
Measured: During 8-hour postdose observation period
Global pain control
The subject was asked the question "How was your pain control overall?" This evaluation was measured on a 5-point categorical scale with 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent.
Measured: At the end of the 8-hour observation period, or at the time the subject took rescue analgesic medication if prior to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startFeb 2004
- Primary completionMar 2004
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egalet Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lincoln Bynum, MD, Study chair, GloboMax (ICON plc)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356225
- Sponsor's protocol ID
- ROX 2003-05
- Status last verified
- Feb 2017
- First submitted
- 16 May 2011
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel, Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery
- ClinicalTrials.gov ID
- NCT01356225
- Acronym / sponsor ID
- ROX 2003-05
- Conditions
- Pain, Dental Impaction
- Keywords
- pain following dental impaction surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Egalet LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Mar 2004 (actual)
- First posted
- 19 May 2011 (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 analgesic efficacy of a single intranasal (IN) administration of ketorolac after dental impaction surgery.
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: Ketorolac tromethamine |
| Intranasal 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 = to 100 pounds and < or = 300 pounds.
- Women of childbearing potential must have 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 = to 50 mm on a 100-mm VAS.
Key exclusion criteria (20 listed)
- Allergy or sensitivity to ketorolac or EDTA.
- Allergic reaction to aspirin or other 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 (AEs).
- 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 tromethamine30 mg Intranasal (2 x 100 uL of a 15% solution), single dose | Drug | Intranasal Ketorolac tromethamine |
| PlaceboIN placebo | Drug | Intranasal placebo |
Primary outcome
Summed Pain Intensity Difference (SPID)
Time frame: 8 hours postdose
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 at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours 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 8 hours.
9 secondary outcomes
Summed Pain Intensity Difference (SPID)
Time frame: 4 and 6 hours postdose
Total Pain Relief (TOTPAR)
Time frame: 4, 6, and 8 hours postdose
Pain intensity difference (PID) and pain relief scores
Time frame: Before receiving study drug (baseline), at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours postdose
Peak PID score
Time frame: 4, 6, and 8 hours postdose
Peak pain relief scores
Time frame: 4, 6, and 8 hours postdose
Time to onset of perceptible pain and meaningful pain relief
Time frame: After study drug administration until perceptible and meaningful pain relief was felt (during the 8-hour postdose observation period)
Time to first use of rescue medication
Time frame: After study drug administration until rescue analgesic therapy was requested (during the 8-hour postdose observation period)
Proportion of subjects taking rescue medication
Time frame: During 8-hour postdose observation period
Global pain control
Time frame: At the end of the 8-hour observation period, or at the time the subject took rescue analgesic medication if prior to 8 hours
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 9 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
GloboMax (ICON plc)
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 Pain and Dental Impaction, run by Egalet Ltd 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 8 inclusion and 20 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 9 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 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. 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?
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?
Summed Pain Intensity Difference (SPID) (time frame: 8 hours postdose). 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 9 Feb 2017.