| Primary | Pain Intensity Difference (PID) on a 0-100 VAS | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint); | Posted | | Least Squares Mean | 95% Confidence Interval | mm | | at 1.5 hours after treatment administration | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 25mg/ml | Diclofenac HPBCD : 1 single injection at day of dental surgical extraction | | OG001 | Diclofenac HPBCD s.c. 50mg/ml | Diclofenac HPBCD : 1 single injection at day of dental surgical extraction | | OG002 | Diclofenac HPBCD s.c. 75mg/ml | Diclofenac HPBCD : 1 single injection at day of dental surgical extraction | | OG003 | Placebo s.c. (1ml) | Placebo s.c. : 1 single injection at day of dental surgical extraction |
| | Units | Counts |
|---|
| Participants | - OG00077
- OG00176
- OG00278
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00036.5(31.7 to 41.2)
- OG00137.3(32.6 to 42.1)
- OG00237.7(33.0 to 42.4)
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration). A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level. | ANCOVA | | < 0.001 | | Mean Difference (Final Values) | 24.2 | | | | | | | | | | No | Superiority or Other | | |
|
| Secondary | PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint); | Posted | | Mean | Standard Deviation | mm | | at 15 minutes post-dose. | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 25mg/ml | | | OG001 | Diclofenac HPBCD s.c. 50mg/ml | | | OG002 | Diclofenac HPBCD s.c. 75mg/ml | | | OG003 | Placebo s.c. 1ml | |
| |
| Secondary | PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint); | Posted | | Mean | Standard Deviation | mm | | at 30 minutes post-dose. | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 25mg/ml | | | OG001 | Diclofenac HPBCD s.c. 50mg/ml | | | OG002 | Diclofenac HPBCD s.c. 75mg/ml | | | OG003 | Placebo s.c. 1ml | |
| |
| Secondary | PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint); | Posted | | Mean | Standard Deviation | mm | | at 45 minutes post-dose. | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 25mg/ml | | | OG001 | Diclofenac HPBCD s.c. 50mg/ml | | | OG002 | Diclofenac HPBCD s.c. 75mg/ml | | | OG003 | Placebo s.c. 1ml | |
| |
| Secondary | PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint); | Posted | | Mean | Standard Deviation | mm | | at 60 minutes post-dose. | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 25mg/ml | | | OG001 | Diclofenac HPBCD s.c. 50mg/ml | | | OG002 | Diclofenac HPBCD s.c. 75mg/ml | | | OG003 | Placebo s.c. 1ml | |
| |
| Secondary | PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint); | Posted | | Mean | Standard Deviation | mm | | at 90 minutes post-dose. | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 25mg/ml | | | OG001 | Diclofenac HPBCD s.c. 50mg/ml | | | OG002 | Diclofenac HPBCD s.c. 75mg/ml | | | OG003 | Placebo s.c. 1ml | |
| |
| Secondary | PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint); | Posted | | Mean | Standard Deviation | mm | | at 2 hours post-dose. | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 25mg/ml | | | OG001 | Diclofenac HPBCD s.c. 50mg/ml | | | OG002 | Diclofenac HPBCD s.c. 75mg/ml | | | OG003 | Placebo s.c. 1ml | |
| |
| Secondary | PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint); | Posted | | Mean | Standard Deviation | mm | | at 3 hours post-dose. | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 25mg/ml | | | OG001 | Diclofenac HPBCD s.c. 50mg/ml | | | OG002 | Diclofenac HPBCD s.c. 75mg/ml | | | OG003 | Placebo s.c. 1ml | |
| |
| Secondary | PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint); | Posted | | Mean | Standard Deviation | mm | | at 4 hours post-dose. | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 25mg/ml | | | OG001 | Diclofenac HPBCD s.c. 50mg/ml | | | OG002 | Diclofenac HPBCD s.c. 75mg/ml | | | OG003 | Placebo s.c. 1ml | |
| |
| Secondary | PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint); | Posted | | Mean | Standard Deviation | mm | | at 5 hours post-dose. | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 25mg/ml | | | OG001 | Diclofenac HPBCD s.c. 50mg/ml | | | OG002 | Diclofenac HPBCD s.c. 75mg/ml | | | OG003 | Placebo s.c. 1ml | |
| |
| Secondary | PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint); | Posted | | Mean | Standard Deviation | mm | | at 6 hours post-dose. | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 25mg/ml | | | OG001 | Diclofenac HPBCD s.c. 50mg/ml | | | OG002 | Diclofenac HPBCD s.c. 75mg/ml | | | OG003 | Placebo s.c. 1ml | |
| |
| Secondary | PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint); | Posted | | Mean | Standard Deviation | mm | | at 7 hours post-dose. | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 25mg/ml | | | OG001 | Diclofenac HPBCD s.c. 50mg/ml | | | OG002 | Diclofenac HPBCD s.c. 75mg/ml | | | OG003 | Placebo s.c. 1ml | |
| |
| Secondary | PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint); | Posted | | Mean | Standard Deviation | mm | | at 8 hours post-dose. | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 25mg/ml | | | OG001 | Diclofenac HPBCD s.c. 50mg/ml | | | OG002 | Diclofenac HPBCD s.c. 75mg/ml | | | OG003 | Placebo s.c. 1ml | |
| |
| Primary | Pain Intensity Difference (PID) on a 0-100 VAS | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint); | Posted | | Least Squares Mean | 95% Confidence Interval | mm | | at 1.5 hours after treatment administration | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 25mg/ml | Diclofenac HPBCD : 1 single injection at day of dental surgical extraction | | OG001 | Diclofenac HPBCD s.c. 50mg/ml | Diclofenac HPBCD : 1 single injection at day of dental surgical extraction | | OG002 | Diclofenac HPBCD s.c. 75mg/ml | Diclofenac HPBCD : 1 single injection at day of dental surgical extraction | | OG003 | Placebo s.c. (1ml) |
|