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| Name | Class |
|---|---|
| Premier Research | OTHER |
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This is a single centre, three-arm randomised, double-blind, double-dummy, parallel group, single-dose, active and placebo-controlled efficacy and pharmacokinetics/ pharmacodynamics study to evaluate the efficacy and safety of 2 x 200 mg Ibuprofen Liquid Capsules in subjects with post-operative dental pain.
Eligible subjects will complete all screening procedures within 28 days before the surgery and randomisation.
At Screening, subjects will provide written informed consent to participate in the study before any protocol specified procedures or assessments are completed. On Day 1, subjects who continue to be eligible for study participation after completing screening procedures and assessments will undergo extraction of 2 or more third molars. At least 1 of the third molars must be a fully or partially bone impacted mandibular molar.
All subjects will receive local anaesthesia (2% lidocaine with 1:100,000 epinephrine). Nitrous oxide will be allowed at the discretion of the investigator. Subjects who experience moderate to severe pain intensity (a score of â„ 5 on a numeric rating scale [NRS] from 0-10 where 0 = no pain, 10 = worst pain ever) within 6 hours after surgery and who continue to meet all study entry criteria will be randomised in a 3:3:1 ratio to receive a single dose of 2Ă200 mg Ibuprofen Liquid Capsules, 2Ă200 mg ibuprofen tablets, or placebo. The randomisation will be stratified by baseline pain category (moderate or severe) using a categorical scale based on the NRS score that includes the categories of none (0), mild (1-4), moderate (5-7), and severe (8-10).
Subjects will re-assess their baseline pain intensity using the NRS immediately before receiving study drug (pre-dose, Time 0) and their pain intensity (NRS) and pain relief (5 point categorical scale) at the following time points (pre-dose, 10, 20, 30 and 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 12 hours after Time 0; and immediately before each dose of rescue medication, if any. For assessments less than 1 hour apart a window of +/-2 min is allowable whilst for assessments at least 1 hour apart a +/-5 min window is allowable.
The double stopwatch method will be used to record the time to perceptible pain relief and time to meaningful pain relief during the 8 hours following the first dose or until subject takes rescue medication. Subjects will complete a global evaluation of study drug and satisfaction with pain relied assessment 12 hours (+/- 5 minutes) after Time 0 or immediately before the first dose of rescue medication (whichever occurs first). Vital signs will be recorded after the subject has been in a sitting position for 3 minutes at the following times: before surgery, within 30 minutes before Time 0, 12 hours after Time 0, immediately before the first dose of rescue medication(if required) and at the follow-up visit. Adverse events (AEs) will be monitored and recorded from the time of signing of the informed consent form (ICF) until the Follow up Visit (or Early Termination Visit). During the 12 hours following Time 0, subjects will complete efficacy and safety assessments. Subjects will remain at the study site overnight and will be discharged on Day 2.
Paracetamol / acetaminophen (1000 mg) will be permitted as the initial rescue medication. Subjects will be encouraged to wait at least 60 minutes after receiving study drug before taking rescue medication. If acetaminophen rescue medication is not effective in relieving the subject's pain, 5 mg oxycodone rescue medication may be administered at the discretion of the investigator.
Subjects are not permitted to take any concomitant medications that might confound assessments of pain relief, such as psychotropic drugs, antidepressants, sedative-hypnotics (other than those permitted for conscious sedation), or other analgesics taken within five times of their elimination half-lives (other than those used at the surgery).
Other restrictions include the following: alcohol use is prohibited from 24 hours before surgery until discharge on Day 2; Food will be restricted from midnight before surgery until 4 hour after surgery; during this time, water may be permitted up to 2 hours prior to surgery and a single drink of 8 fluid ounces of water with their treatment, water will not be permitted until 1 hour post dose. Vaccinations should not have been administered 7 days prior to surgery, subjects should avoid strenuous physical activity from 72 hours prior to dosing, and will not be permitted to smoke or use nicotine containing products for the duration of their involvement in the study.
A subset of 70 subjects will be randomly selected from the study population to take part in a Pharmacokinetic sub study. Blood samples will be collected at 10, 15, 20, 30 and 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 12 hours post dose.
Upon discharge from the study site, subjects may be prescribed pain medication for use at home according to the standard practice of the study site. On Day 8 (± 2 days), subjects will return to the study site for an abbreviated confirmatory physical assessment and AE assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product | Experimental | Ibuprofen 200mg Oral Liquid Capsule, Placebo of Ibuprofen 200mg Oral Tablet |
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| Reference Product | Active Comparator | Ibuprofen 200mg Oral Tablet, Placebo of Ibuprofen 200mg Oral Liquid Capsule |
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| Placebo | Placebo Comparator | Placebo of Ibuprofen 200mg Oral Liquid Capsule, Placebo of Ibuprofen 200mg Oral Tablet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 200Mg Oral Cap | Drug | 2 x 200mg Liquid Capsules once in 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summed Pain Intensity Difference 0-8 hours (SPID0-8) vs placebo using the Numeric Rating Scale (NRS) for pain | SPID0-8 will be used to compare the test product against the placebo product. Pain Intensity Difference (Difference in NRS for baseline and each timepoint) will be plotted against timepoint up to the 8 hour timepoint, the SPID0-8 will be take as the area under the curve. The NRS will be used to assess the Pain Intensity, the NRS for pain is an 11-point scale (0-10) where a higher score indicates a greater amount of pain. | 0-8 hours |
| Time to Meaningful pain relief vs active comparator using double stopwatch method | Time to onset of meaningful pain relief (measured as time to meaningful pain relief) using double stopwatch will be used to compare the test product with the active comparator. Two stopwatches will be started immediately after the subject has swallowed the study drug with 8 ounces of water. Each subject will be instructed, "Stop the first stopwatch when you first feel any pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief in the pain you have now" (perceptible pain relief). The subject will also be instructed, "Stop the second stopwatch when you feel the pain relief is meaningful to you" (meaningful pain relief). If the subject does not press the stopwatches within 8 hours after Time 0 the subject will discontinue use of the stopwatches. | 0-8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of pain relief using double stopwatch method vs Placebo | Time to onset of meaningful pain relief (measured as time to perceptible pain relief confirmed by time to meaningful pain relief) using double stopwatch will be used to compare test product with placebo. Two stopwatches will be started immediately after the subject has swallowed the study drug with 8 ounces of water. Each subject will be instructed, "Stop the first stopwatch when you first feel any pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief in the pain you have now" (perceptible pain relief). The subject will also be instructed, "Stop the second stopwatch when you feel the pain relief is meaningful to you" (meaningful pain relief). If the subject does not press the stopwatches within 8 hours after Time 0 the subject will discontinue use of the stopwatches. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events as assessed by patient response to questions and spontaneous reporting of TEAEs | Incidence of treatment emergent adverse events (TEAEs). Data listings will be provided for protocol specified safety data. | 0-10 days |
| Vital signs measurements - Blood pressure in mm/Hg |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Bertoch, MD | JBR Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11690728 | Background | Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9. | |
| 9515184 | Background | Davies NM. Clinical pharmacokinetics of ibuprofen. The first 30 years. Clin Pharmacokinet. 1998 Feb;34(2):101-54. doi: 10.2165/00003088-199834020-00002. |
| Label | URL |
|---|---|
| Guidance for Industry Food-Effect Bioavailability and Fed Bioequivalence Studies | View source |
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The dental pain model used in this study is a robust and well established postsurgical pain model that produces pain that is predictable in its character, duration, and intensity. The model is widely accepted and has a proven record of assay sensitivity (i.e. separating active drugs from each other, as well as from placebo). The model is frequently used to evaluate NSAID type analgesics. Results from dental pain studies are accepted by the US Food and Drug Administration (FDA) and European authorities and have been widely extrapolated to other general pain conditions.
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This is a double-blind, double dummy study. There will be two placebo tablets designed to be comparable to each of the active products (200mg Ibuprofen Liquid Capsules and 200mg Ibuprofen Tablets) in both shape, size, colour and weight. All subject packs have been designed and labelled to ensure blinding is maintained. Subjects, investigators and site staff will all be blind to the treatments.
| Ibuprofen 200Mg Oral Tablet | Drug | 2 x 200mg Tablets once in 12 hours |
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| Placebo Liquid Capsule | Other | 2 x Liquid Capsules once in 12 hours |
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| Placebo Tablets | Other | 2 x Tablets once in 12 hours |
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| 0-8 hours |
| Total Pain Relief 0-6 hours (TOTPAR6) for Test Product vs Active Comparator After Time 0 | TOTPAR6 after Time 0 will be assessed using the Pain Relief Scale (PRS) will be used to compare test product to active comparator. Pain Relief Scores (PRS) will be plotted against each timepoint up to the 6 hour timepoint, TOTPAR6 is the area under the curve. PRS is a 5 point categorical scale, response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". | 0-6 hours |
| Proportion of subjects using rescue medication vs Active Comparator | Proportion of subjects using rescue medication within the first 6 hours will be used to compare the test product against active comparator | 0- 6 hours |
| Time to first use of rescue medication vs Active Comparator | Time to first use of rescue medication will be used to compare the test product and active comparator. | 0-12 hours |
| Time to onset of pain relief using double stopwatch method vs Active Comparator | Time to onset of meaningful pain relief (measured as time to perceptible pain relief confirmed by time to meaningful pain relief) using double stopwatch will be used to compare test product with Active Comparator. Two stopwatches will be started immediately after the subject has swallowed the study drug with 8 ounces of water. Each subject will be instructed, "Stop the first stopwatch when you first feel any pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief in the pain you have now" (perceptible pain relief). The subject will also be instructed, "Stop the second stopwatch when you feel the pain relief is meaningful to you" (meaningful pain relief). If the subject does not press the stopwatches within 8 hours after Time 0 the subject will discontinue use of the stopwatches. | 0-8 hours |
| Proportion of Subjects achieving at least "a lot" of pain relief at 1 and 2 hours post dose vs Placebo and Active Comparator | Proportion of subjects achieving at least "a lot" of pain relief measured using PRS at 1 and 2 hours after Time 0 will be used to compare the test product (2 x 200 mg Ibuprofen Liquid Capsules) against active comparator (2 x 200 mg standard ibuprofen tablets) and the test product (2 x 200 mg Ibuprofen Liquid Capsules) against placebo. The PRS will be used to measure pain relief and is a 5 point categorical scale, response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". | 0-2 hours |
| Proportion of subjects using rescue medication vs Placebo | Proportion of subjects using rescue medication within the first 6 hours will be used to compare the test product against Placebo | 0-6 hours |
| Proportion of subjects using rescue medication vs Placebo and Active Comparator | Proportion of subjects using rescue medication within the first 12 hours will be used to compare the test product against Placebo and Active Comparator | 0-12 hours |
| Time to peak pain relief using Pain Relief Scale (PRS) vs active comparator and placebo | The time to reach peak pain relief will be compared vs active comparator and placebo. The PRS will be used to measure pain relief and is a 5 point categorical scale, response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". | 0-12 hours |
| Proportion of subjects with "Complete" pain relief at 30 minutes, assessed using PRS, after Time 0 vs Active Comparator and Placebo | The proportion of subjects with complete pain relief at 30 minutes, assessed using PRS after T 0 will be compared vs active comparator and placebo. The PRS will be used to measure pain relief and is a 5 point categorical scale, response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". | 0-12 hours |
| Proportion of subjects with "Complete" pain relief at 30 minutes, assessed using PRS, after Time 0 vs Active Comparator and Placebo | The proportion of subjects with at least a 50% decrease in pain intensity at 30 minutes after T0 (using NRS for pain) compared to active comparator and placebo. The NRS for pain is an 11-point scale (0-10) where a higher score indicates a greater amount of pain. | 0-30 minutes |
| Proportion of subjects with at least 50% decrease in pain intensity at any time 6 hours after T0 using NRS vs active comparator and placebo | The proportion of subjects with at least a 50% decrease in pain intensity at any time 6 hours after T0 (using NRS for pain) compared to active comparator and placebo. The NRS for pain is an 11-point scale (0-10) where a higher score indicates a greater amount of pain. | 0-6 hours |
| Time to first use of rescue medication vs Placebo | Time to first use of rescue medication will be used to compare the test product and placebo. | 0-12 hours |
| Total Pain Relief 0-2 hours (TOTPAR2) for Test Product vs Active Comparator After Time 0 | TOTPAR2 after Time 0 will be assessed using the Pain Relief Scale (PRS) will be used to compare test product to active comparator. Pain Relief Scores (PRS) will be plotted against each timepoint up to the 2 hour timepoint, TOTPAR2 is the area under the curve. PRS is a 5 point categorical scale, response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". | 0-2 hours |
| Total Pain Relief 0-4 hours (TOTPAR4) for Test Product vs Active Comparator After Time 0 | TOTPAR4 after Time 0 will be assessed using the Pain Relief Scale (PRS) will be used to compare test product to active comparator. Pain Relief Scores (PRS) will be plotted against each timepoint up to the 4 hour timepoint, TOTPAR4 is the area under the curve. PRS is a 5 point categorical scale, response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". | 0-4 hours |
| Total Pain Relief 0-8 hours (TOTPAR8) for Test Product vs Active Comparator After Time 0 | TOTPAR8 after Time 0 will be assessed using the Pain Relief Scale (PRS) will be used to compare test product to active comparator. Pain Relief Scores (PRS) will be plotted against each timepoint up to the 8 hour timepoint, TOTPAR8 is the area under the curve. PRS is a 5 point categorical scale, response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". | 0-8 hours |
| PK Subset: Cmax will be evaluate for each treatment (test and active comparator) | The Cmax (Maximum Plasma Concentration) will be calculated for the test and active comparator. | 0-12 hours |
| PK Subset: tmax will be evaluate for each treatment (test and active comparator) | The tmax (Time of maximum plasma concentration) will be calculated for the test and active comparator. | 0-12 hours |
| PK Subset: AUC0-t will be evaluate for each treatment (test and active comparator) | The AUC0-t (Area under the plasma concentration-time curve from time zero to the last quantifiable plasma concentration) will be calculated for the test and active comparator. | 0-12 hours |
| PK Subset: tlag will be evaluate for each treatment (test and active comparator) | The tlag (the time delay between drug administration and first observed concentration) will be calculated for the test and active comparator. | 0-12 hours |
| Minimum Effective Concentration (MEC) for onset of analgesia (SC1) and meaningful pain relief (SC2)- test product (TP) and active comparator (AC), and combined (COM) | The proportion of subjects with confirmed pain relief (assessed via timepoint 1 in the double stopwatch method) at 10, 15, 20, 30, 45, 60, 75 and 90 minutes. The first timepoint at which the incidence of confirmed time to onset of pain (stop clock 1, SC1) is statistically significantly (p<0.05) greater than placebo will be calculated for each treatment group, these will be termed SC1(TP) for the test product and SC1(AC) for the active comparator. The same methodology will be followed to determine the first timepoint at which the confirmed meaningful pain relief (timepoint 2 in the double stopwatch method) at 10, 15, 20, 30, 45, 60, 75 and 90 minutes is statistically significantly greater (p<0.05) than placebo will be calculated for each treatment group, these will be termed SC2(TP) and SC2(AC). The mean ibuprofen plasma concentration (including chiral analysis) by treatment group (and combined) is considered the minimum effective concentration. | 10-90mins |
| Occupancy Time | Occupancy time will be calculated for both test and comparator products individually and as a combination, a ratio of time where ibuprofen (both racemic and s enantiomer) plasma levels are above MEC.SC1 and MEC.SC2 will be reported for the test product, active comparator and a combination of the two. | 0-12 hours |
| Time to meaningful pain relief compared to the placebo | Time to onset of meaningful pain relief (measured as time to perceptible pain relief confirmed by time to meaningful pain relief) using double stopwatch will be used to compare the test product with the placebo. Two stopwatches will be started immediately after the subject has swallowed the study drug with 8 ounces of water. Each subject will be instructed, "Stop the first stopwatch when you first feel any pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief in the pain you have now" (perceptible pain relief). The subject will also be instructed, "Stop the second stopwatch when you feel the pain relief is meaningful to you" (meaningful pain relief). If the subject does not press the stopwatches within 8 hours after Time 0 the subject will discontinue use of the stopwatches. | 0-8 hours |
| Total Pain Relief 0-2 hours (TOTPAR2) for Test Product vs Placebo | TOTPAR2 after Time 0 will be assessed using the Pain Relief Scale (PRS) will be used to compare test product to Placebo. Pain Relief Scores (PRS) will be plotted against each timepoint up to the 2 hour timepoint, TOTPAR2 is the area under the curve. PRS is a 5 point categorical scale, response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". | 0-2 hours |
| Total Pain Relief 0-4 hours (TOTPAR4) for Test Product vs Placebo | TOTPAR4 after Time 0 will be assessed using the Pain Relief Scale (PRS) will be used to compare test product to Placebo. Pain Relief Scores (PRS) will be plotted against each timepoint up to the 4 hour timepoint, TOTPAR4 is the area under the curve. PRS is a 5 point categorical scale, response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". | 0-4 hours |
| Total Pain Relief 0-6 hours (TOTPAR6) for Test Product vs Placebo | TOTPAR6 after Time 0 will be assessed using the Pain Relief Scale (PRS) will be used to compare test product to Placebo. Pain Relief Scores (PRS) will be plotted against each timepoint up to the 6 hour timepoint, TOTPAR6 is the area under the curve. PRS is a 5 point categorical scale, response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". | 0-6 hours |
| Total Pain Relief 0-8 hours (TOTPAR8) for Test Product vs Placebo | TOTPAR8 after Time 0 will be assessed using the Pain Relief Scale (PRS) will be used to compare test product to Placebo. Pain Relief Scores (PRS) will be plotted against each timepoint up to the 8 hour timepoint, TOTPAR4 is the area under the curve. PRS is a 5 point categorical scale, response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". | 0-8 hours |
| Pain intensity Score at each scheduled timepoint After Time 0 | Pain intensity score at each scheduled time point will be assessed using a numeric rating scale (NRS) for pain. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain | 0-12 hours |
| Pain intensity difference score at each scheduled timepoint after Time 0. | Pain intensity score at each scheduled time point will be assessed using a numeric rating scale (NRS) for pain. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain | 0-12 hours |
| Summed Pain Intensity Difference over 0 to 2 hours (SPID2), test product vs active comparator and test vs against placebo using the Numeric Rating Scale (NRS) for pain. | SPID2 will be used to compare the test product against the comparator and placebo product. Pain Intensity Difference (Difference in NRS for baseline and each timepoint) will be plotted against timepoint up to the 2 hour timepoint, the SPID2 will be take as the area under the curve. The NRS will be used to assess the Pain Intensity, the NRS for pain is an 11-point scale (0-10) where a higher score indicates a greater amount of pain. | 0-2 hours |
| Summed Pain Intensity Difference over 0 to 4 hours (SPID4), test product vs active comparator and test vs against placebo using the Numeric Rating Scale (NRS) for pain. | SPID4 will be used to compare the test product against the comparator and placebo product. Pain Intensity Difference (Difference in NRS for baseline and each timepoint) will be plotted against timepoint up to the 4 hour timepoint, the SPID4 will be take as the area under the curve. The NRS will be used to assess the Pain Intensity, the NRS for pain is an 11-point scale (0-10) where a higher score indicates a greater amount of pain. | 0-4 hours |
| Summed Pain Intensity Difference over 0 to 6 hours (SPID6), test product vs active comparator and test vs against placebo using the Numeric Rating Scale (NRS) for pain | SPID6 will be used to compare the test product against the comparator and placebo product. Pain Intensity Difference (Difference in NRS for baseline and each timepoint) will be plotted against timepoint up to the 2 hour timepoint, the SPID0-2 will be take as the area under the curve. The NRS will be used to assess the Pain Intensity, the NRS for pain is an 11-point scale (0-10) where a higher score indicates a greater amount of pain. | 0-6 hours |
| Time to first perceptible pain relief. | Two stopwatches were started immediately after the subject swallowed the study drug. Subjects were instructed to, "Stop the first stopwatch when you first feel any pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief in the pain you have now" (perceptible pain relief). Time to first perceptible pain relief was date/time of the first reported pain relief (any) as assessed by the subject (i.e., when the subject stopped the first stopwatch, irrespective of the second) - date/time of the first dose of study drug. If the stopwatch were not stopped within 8 hours after Time 0, use of the stopwatches was discontinued. | 0-8 hours |
| Pain relief score at each scheduled time point after Time 0. | Pain relief score at each scheduled time point after Time 0 was measured using the Pain Relief Scale (PRS). The PRS was used to measure pain relief and is a 5-point categorical scale, with response choices of: none = 0; a little = 1; some = 2; a lot = 3; and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome. | 0-12 hours |
| Subject's global evaluation of study drug. | Patient's global evaluation of study drug using 5 point categorical scale, response choices of 0 = poor, 1 = fair, 2 = good, 3 = very good, or 4 = excellent to be completed by the patient in response to the question "How effective do you think the study drug is as a treatment for pain?". Subjects will complete the global evaluation of study drug 24 hours after Time 0 or immediately before the first dose of rescue medication (whichever occurs first). | 0-12 hours |
| Subject satisfaction with pain relief. | Patient's global evaluation of pain relief using 5 point categorical scale, response choices of Very Satisfied, Satisfied, Neither Satisfied nor Dissatisfied, Dissatisfied or Very Dissatisfied to be completed by the patient in response to the question "How satisfied are you with the pain relief provided by the study medication?". Subjects will complete the global evaluation of study drug 24 hours after Time 0 or immediately before the first dose of rescue medication (whichever occurs first). | 0-12 hours |
| Peak pain relief. | Peak pain relief at each time point will be measured using the Pain Relief Scale (PRS). The PRS will be used to measure pain relief and is a 5-point categorical scale, response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome. The peak pain relief each subject achieved will be summarised. | 0-12 hours |
| Summed pain relief and intensity difference (sum of TOTPAR and SPID [SPRID]) over 0 to 4 hours (SPRID4). | Pain Intensity Difference (Difference in NRS for baseline and each timepoint) will be plotted against timepoint up to the 4 hour timepoint, the SPID4 will be calculated as the area under the curve. Pain Relief Scores (PRS) will be plotted against each timepoint up to the 4 hour timepoint, TOTPAR4 is the area under the curve. SPRID4 is SPID4 + TOTPAR4. The PRS was used to measure pain relief and is a 5-point categorical scale with response choices of: none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome. An 11-point (0-1) NRS for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain. | 0-4 hours |
| Summed pain relief and intensity difference (sum of TOTPAR and SPID [SPRID]) over 0 to 8 hours (SPRID8). | Pain Intensity Difference (Difference in NRS for baseline and each timepoint) will be plotted against timepoint up to the 4 hour timepoint, the SPID8 will be calculated as the area under the curve. Pain Relief Scores (PRS) will be plotted against each timepoint up to the 8 hour timepoint, TOTPAR8 is the area under the curve. SPRID8 is SPID8 + TOTPAR8. The PRS was used to measure pain relief and is a 5-point categorical scale with response choices of: none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome. An 11-point (0-1) NRS for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain. | 0-8 hours |
| The summed pain intensity difference (SPID) over 0 to 8 hours (SPID8) will be used to compare the test product and active comparator product. | SPID8 was used to compare the test product to the comparator product. Pain Intensity Difference (Difference in NRS for baseline and each timepoint) will be plotted against timepoint up to the 8 hour timepoint, the SPID0-8 will be take as the area under the curve. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain. | 0-8 hours |
| Proportion of subjects who achieve at least 50% of the maximum TOTPAR (maxTOTPAR) over 0 to 6 hours will be used to compare the test product against active comparator and the placebo | The proportion of subjects who achieve at least 50% of the maxTOTPAR in the first 6 hours will be used to compare the test product to comparator and placebo test groups. Pain Relief Scores (PRS) will be plotted against each timepoint up to the 6 hour timepoint, TOTPAR6 is the area under the curve. The maxTOTPAR is the maximum total pain relief score (TOTPAR) possible up to and including the 6 hour timepoint. Each subjects TOTPAR will be assessed against the maxTOTPAR and the proportion who reach a value of at least 50% of this value will be used to assess this endpoint. The Pain Relief Scale (PRS) will be used to measure pain relief and is a 5-point categorical scale with response choices of: none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome. | 0-6 hours |
| Relationship between speed of onset of pain relief and overall pain over 0-60 minutes. | To assess the relationship between speed of onset of pain relief and overall pain experience by evaluating the association between the slope of the change in pain intensity over 0-60 minutes and %maxTOTPAR over 0-60 minutes. Pain Intensity scores using the NRS will be plotted against each timepoint up to the 1 hour timepoint. Pain Relief Scores (PRS) will be plotted against each timepoint up to the 1 hour timepoint, Total Pain Relief 0-1 hours (TOTPAR1) is the area under the curve. Each subjects TOTPAR1 will be expressed as a % of maxTOTPAR and compared to the slope of the change in pain intensity. The NRS will be used to assess the Pain Intensity, the NRS for pain is an 11-point scale (0-10) where a higher score indicates a greater amount of pain. PRS is a 5 point categorical scale, response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 to be completed in response to the question "How much relief have you had since your starting pain?". | 0-1 hours |
| Relationship between speed of onset of pain relief and time to rescue medication over 0-60 minutes. | To assess the relationship between speed of onset of pain relief and time to rescue medication by evaluating the association between the slope of the change in pain intensity over 0-60 minutes and time to rescue medication. | 0-1 hour |
Incidence of changes in vital sign measurements. Descriptive statistics will be provided at each scheduled time point for each treatment group. Changes from Baseline for vital signs will be calculated for each subject. |
| 0-10 days |
| Vital signs measurements - Heart rate in beats per minute | Incidence of changes in vital sign measurements. Descriptive statistics will be provided at each scheduled time point for each treatment group. Changes from Baseline for vital signs will be calculated for each subject. | 0-10 days |
| Vital signs measurements - Respiratory rate in breaths per minute | Incidence of changes in vital sign measurements. Descriptive statistics will be provided at each scheduled time point for each treatment group. Changes from Baseline for vital signs will be calculated for each subject | 0-10 days |
| Vital signs measurements - Body Temperature in ÂșC | incidence of changes in vital sign measurements. Descriptive statistics will be provided at each scheduled time point for each treatment group. Changes from Baseline for vital signs will be calculated for each subject. | 0-10 days |
| 26683233 | Background | Cooper SA, Desjardins PJ, Turk DC, Dworkin RH, Katz NP, Kehlet H, Ballantyne JC, Burke LB, Carragee E, Cowan P, Croll S, Dionne RA, Farrar JT, Gilron I, Gordon DB, Iyengar S, Jay GW, Kalso EA, Kerns RD, McDermott MP, Raja SN, Rappaport BA, Rauschkolb C, Royal MA, Segerdahl M, Stauffer JW, Todd KH, Vanhove GF, Wallace MS, West C, White RE, Wu C. Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations. Pain. 2016 Feb;157(2):288-301. doi: 10.1097/j.pain.0000000000000375. |
| 23163542 | Background | Mehlisch DR, Sykes J. Ibuprofen blood plasma levels and onset of analgesia. Int J Clin Pract Suppl. 2013 Jan;(178):3-8. doi: 10.1111/ijcp.12053. |
| Guideline on the clinical development of medicinal products intended for the treatment of pain | View source |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 14, 2024 | Jul 11, 2024 | 3 | ||
| Jul 12, 2024 | Aug 7, 2024 | 4 | ||
| Sep 9, 2024 | Sep 9, 2024 | 5 |
| ID | Term |
|---|---|
| D014095 | Tooth, Impacted |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D002214 | Capsules |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided