A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain

VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled no pain (0 mm) as the left anchor and worst possible pain (100 mm) as the right anchor. A positive change represents a reduction in pain.

Time frame: 60 minutes postdose

Population: The efficacy analyses were performed on the full analysis set (FAS) which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.

VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their pain intensity using the 100 mm VASPI to indicate their current level of pain intensity on the 100 mm VASPI labeled no pain (0 mm) as the left anchor and worst possible pain (100 mm) as the right anchor. A positive change shows reduction in pain. AUC of VASPI reduction from baseline for each time point was calculated using the trapezoidal rule.

Time frame: 15, 30, 45, 60 and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose

Population: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.

VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled no pain (0 mm) as the left anchor and worst possible pain (100 mm) as the right anchor. A positive change represents a reduction in pain.

Time frame: 15, 30, 45, and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose

Population: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.

Duration of analgesia (time to first use of rescue medication) was evaluated, from dose administration to the time of first use of rescue medication within the 8-hour treatment period. Censored observations were included in calculating this endpoint. Censored subjects include any subject who did not take rescue medication prior to the end of the assessment period of 480 minutes (8 hours).

Time frame: From dose administration to 8 hours post dose

Population: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.

The number of patients needing rescue medication within the 8 hour treatment period was evaluated.

Time frame: From dose administration to 8 hours post dose

Population: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.

Treatment emergent adverse events are reported in the below data table.

Time frame: time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)

Population: Safety analyses were performed on the safety set, which included all randomized subjects who were exposed to study drug.

PGART was measured by asking patients to give a score on a scale from 0 to 4, where 0 = poor; 1 = fair; 2 = good; 3 = very good; 4 = excellent. This measurement was taken at the end of 8 hours, or before the use of rescue medication (for a patient who takes rescue medciation within the 8 hour period).

Time frame: At 8 hour postdose prior to use of rescue medication

Population: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.

Peak analgesic relief is represented through highest pain intensity difference (PID), highest VASPI reduction, and highest pain relief scores. Pain intensity was measured on a verbal rating scale (VRS) ranging from 0 to 3 (none to severe, with higher score for higher pain intensity). PID represents difference in this score at baseline and specific time points, larger change indicating larger reduction in pain, with highest PID representing the largest difference. Pain relief was recorded on a scale ranging from 0 to 4 (none to complete, with higher score for higher pain relief), with highest pain relief representing maximum relief obtained. Pain intensity was also measured through a 100 mm visual analogue scale (VASPI), ranging from no pain (0 mm) to worst possible pain (100 mm). A positive change in VASPI indicates reduction in pain, with highest VASPI reduction representing highest change.

Time frame: From dose administration to 8 hours post dose

Population: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.

After the administration of the single dose of the assigned study treatment, at the defined study time points, the clinical site staff captured pain relief information from each subject. The subject was asked What is the amount of pain relief as compared to the starting pain? and the response was recorded as 0 = none, 1 = a little, 2 = some, 3 = a lot, or 4 = complete. Total pain relief (TOTPAR) was the weighted sum of the pain relief scores from the 15-minute to the 8-hour observation points (TOTPAR8). Additionally, TOTPARs at 1, 2, 4 and 6 hours were calculated. The weights used for these values (evaluation time points) were 0.25 for the 15-, 30-, 45-, and 60-minute observations, 0.5 for the 90-minute, 2- and 4-hour observations, and 1 for the remaining observations.

Time frame: 1, 2, 4, 6, and 8 hours postdose

Population: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.

At baseline and at each defined study time point, the clinical site staff captured pain intensity information from each subject using the 4-point categorical VRS. The subject was asked What is your pain level at this time? and the response was recorded as 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Pain intensity difference (PID) was the difference between the baseline pain intensity score and the pain intensity score at a specific observation point. SPID is the weighted sum of PIDs from the 15-minute to the 8-hour observation point (SPID8). Additionally, SPID evaluations were also be done at 1 (SPID1), 2 (SPID2), 4 (SPID4) and 6 (SPID6) hours post dose. The weights used for these values were 0.25 for the 15-, 30-, 45-, and 60-minute observations, and 0.5 for the 90-minute, 2- and 4-hour observations, and 1 for the remaining observations.

Time frame: 1, 2, 4, 6, and 8 hours postdose

Population: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.

Time to onset of first perceptible pain relief (FPR), provided the FPR was subsequently 'confirmed' through the achievement of meaningful pain relief (MPR). Participant started two stopwatches at dosing, and recorded FPR by stopping the first stopwatch when he/she first experienced 'any' pain relief. FPR is 'confirmed' only if the participant also stopped the second stopwatch indicating 'meaningful pain relief'.

Time frame: Within 8 hours postdose

Population: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.

Using the double stopwatch technique, participant started two stopwatches at dosing, and stopped the first stopwatch as soon as he/she first began to feel 'any' relief from pain. The time elapsed was recorded as the FPR.

Time frame: Within 8 hours postdose

Population: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.

Using the double stopwatch technique, participant started two stopwatches at dosing, and stopped the second stopwatch as soon as he/she began to experience 'meaningful' relief from pain. Time elapsed is recorded as the MPR.

Time frame: Within 8 hours postdose

Population: The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.