Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

List	Outcome	Time frame	Description
Primary	Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)	Every two hours from Baseline to 6 hours post dose	SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline \[pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)\]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief\]
Secondary	Time to Confirmed First Perceptible Relief	Baseline to 6 hours post dose	Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
Secondary	Time to Onset of Meaningful Pain Relief	Baseline to 6 hours post dose	Participants recorded the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.
Secondary	Time to Start Using Rescue Medication	Baseline to 6 hours post dose	Median time of use of rescue medication by participants.
Secondary	Percentage of Participants Who Took Rescue Medication at 2 Hours	Baseline to 2 hours post dose	Percentage of participants who received rescue medication at different time points post dose.
Secondary	Percentage of Participants Who Took Rescue Medication at 6 Hours	Baseline to 6 hours post dose	Percentage of participants who received rescue medication at different time points post dose.
Secondary	SPRID at 2 Hours	Every two hours from baseline to 2 hours post dose	SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline \[pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)\]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief
Secondary	SPRID at 4 Hours	Every two hours from baseline to 4 hours post dose	SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline \[pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)\]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief
Secondary	Total Pain Relief Score (TOTPAR) at 2 Hours	Every two hours from baseline to 2 hours post dose	TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief. TOTPARt = ∑PR x (timet - timet-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale \[0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief\].
Secondary	TOTPAR at 4 Hours	Every two hours from baseline to 4 hours post dose	TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief. TOTPARt = ∑PR x (timet - timet-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale \[0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief\].
Secondary	TOTPAR at 6 Hours	Every two hours from baseline to 6 hours post dose	TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief. TOTPARt = ∑PR x (timet - timet-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale \[0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief\].
Secondary	Sum of Pain Intensity Difference (SPID) Scores at 2 Hours	Every two hours from baseline to 2 hours post dose	SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (timet - timet-1) Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain. If the subject rated pain intensity as "2" or "3", pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.
Secondary	SPID Scores at 4 Hours	Every two hours from baseline to 4 hours post dose	SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (timet - timet-1) Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain. If the subject rated pain intensity as "2" or "3", pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.
Secondary	SPID Scores at 6 Hours	Every two hours from baseline to 6 hours post dose	SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (timet - timet-1) Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain. If the subject rated pain intensity as "2" or "3", pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.
Secondary	Participants Global Assessment to Response to Treatment (PGART)	Baseline to 6 hours post dose	PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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