| Primary | Pain Intensity Difference (PID) | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | Analysed patients are those included in the PP population: all patients included in the ITT population who also met all inclusion/exclusion criteria and who did not have any major protocol violation, and with post-surgical pain assessment at the primary endpoint. | Posted | | Least Squares Mean | 95% Confidence Interval | mm | | 1.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 75mg/ml | Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction | | OG001 | Voltarol 75mg/3ml i.m. | Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00044.8± 40.5 to 49.1(40.5 to 49.1)
- OG00145.5(41.2 to 49.8)
|
|
| | 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 |
|---|
| Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis. | ANCOVA | | 0.813 | | Mean Difference (Final Values) | -0.71 | | | 2-Sided | 95 | -6.62 | 5.20 | | | | Yes | Non-Inferiority or Equivalence | The sample size calculation was based on a hypothesis of non-inferiority of Diclofenac HPBCD 75mg/ml s.c. versus Voltarol® 75mg/3ml i.m. with regard to the primary efficacy variable (PID at 1.5 hours after study drug administration). The clinically significant difference (delta) between groups was defined in 15 mm of pain intensity difference (a 30% decline from starting levels of pain intensity of 50 mm or greater on a 0 to 100 VAS). |
|
| Secondary | PIDs | | Analysed patients were included in the ITT population: 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. 75mg/ml | Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction | | OG001 | Voltarol 75mg/3ml i.m. | Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction |
| |
| Secondary | PIDs | | Analysed patients were included in the ITT population: 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. 75mg/ml | Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction | | OG001 | Voltarol 75mg/3ml i.m. | Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction |
| |
| Secondary | PIDs | | Analysed patients were included in the ITT population: 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. 75mg/ml | Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction | | OG001 | Voltarol 75mg/3ml i.m. | Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction |
| |
| Secondary | PIDs | | Analysed patients were included in the ITT population: 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. 75mg/ml | Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction | | OG001 | Voltarol 75mg/3ml i.m. | Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction |
| |
| Secondary | PIDs | | Analysed patients were included in the ITT population: 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. 75mg/ml | Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction | | OG001 | Voltarol 75mg/3ml i.m. | Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction |
| |
| Secondary | PIDs | | Analysed patients were included in the ITT population: 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. 75mg/ml | Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction | | OG001 | Voltarol 75mg/3ml i.m. | Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction |
| |
| Secondary | PIDs | | Analysed patients were included in the ITT population: 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. 75mg/ml | Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction | | OG001 | Voltarol 75mg/3ml i.m. | Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction |
| |
| Secondary | PIDs | | Analysed patients were included in the ITT population: 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. 75mg/ml | Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction | | OG001 | Voltarol 75mg/3ml i.m. | Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction |
| |
| Secondary | PIDs | | Analysed patients were included in the ITT population: 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. 75mg/ml | Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction | | OG001 | Voltarol 75mg/3ml i.m. | Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction |
| |
| Secondary | PIDs | | Analysed patients were included in the ITT population: 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. 75mg/ml | Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction | | OG001 | Voltarol 75mg/3ml i.m. | Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction |
| |
| Secondary | PIDs | | Analysed patients were included in the ITT population: 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. 75mg/ml | Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction | | OG001 | Voltarol 75mg/3ml i.m. | Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction |
| |
| Secondary | PIDs | | Analysed patients were included in the ITT population: 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. 75mg/ml | Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction | | OG001 | Voltarol 75mg/3ml i.m. | Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction |
| |
| Primary | Pain Intensity Difference (PID) | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | Analysed patients are those included in the ITT population: defined as all randomised patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose. | Posted | | Least Squares Mean | 95% Confidence Interval | mm | | 1.5 hours | | | | ID | Title | Description |
|---|
| OG000 | Diclofenac HPBCD s.c. 75mg/ml | Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction | | OG001 | Voltarol 75mg/3ml i.m. | Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction |
| |