| Primary | Time to First Achieve a Numeric Rating Scale-Pain Intensity Score <4 or a Pain Intensity Reduction of ≥30% From Drug Intake Till 8 Hours After the First Dose | Time to first achieve a Numeric Rating Scale-Pain Intensity (NRS-PI) score of <4 or a pain intensity reduction ≥30% from drug intake till 8 hours after the first dose. Numeric Rate Scale-Pain Intensity is a Patients rated Pain Intensity scale using an 11-point Numeric Rate Scale (0 no pain; 10 worst pain). | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. Tramadol Hydrochloride 100 mg is not applicable for primary outcome measure since the primary objective was "To evaluate the analgesic efficacy of Dexketo/Tram fixed combination versus placebo in moderate to severe acute low back pain after the first dose (first 8 hours)" | Posted | | Mean | Full Range | score on a scale | | 8 hours from first intake (referring to first 8 hours of Single Dose Phase) | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/ Tramadol Hydrochloride 75 mg Treatment (Both Phases) | Two phase intervention. Single dose phase (SDP) (time 0 - time 8h) and Multiple dose phase (MDP) time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours | | OG001 | Placebo (SDP) Then Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment (MDP) | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5). SINGLE DOSE PHASE (SDP): Placebo film-coated tablets matching Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg MULTIPLE DOSE PHASE (MDP): Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours Placebo: Administered as one tablet if matching Dexketoprofen Trometamol 25 mg and Tramadol Hydrochloride 75 mg or two capsules if matching Tramadol Hydrochloride 100 mg | | OG002 | Placebo (Single Dose Phase) Then Tramadol Hydrochloride 100 mg (Multiple Dose Phase) | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5). SINGLE DOSE PHASE (SDP): Placebo capsules matching active comparator (administered as 2 capsules of Tramadol 50 mg) MULTIPLE DOSE PHASE (MDP): Tramadol Hydrochloride 100 mg (administered as 2 capsules of Tramadol 50 mg) Tramadol Hydrochloride 100 mg: Administered as two capsules with 50 mg each to be taken every 8 hours Placebo: Administered as one tablet if matching Dexketoprofen Trometamol 25 mg and Tramadol Hydrochloride 75 mg or two capsules if matching Tramadol Hydrochloride 100 mg |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
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| - OG000105(15 to 480)
- OG001120(15 to 360)
- OG002120(15 to 360)
|
|
| | 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 |
|---|
| | t-test, 2 sided | | =0.566 | | | | | | | | | | | | | | Superiority | | |
|
| Secondary | Total Pain Relief (TOTPAR) at 4h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol | TOTPAR was calculated as the time-weighted sum of the PAR- (VRS) scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 16 for Dexketoprofen/Tramadol group and 0 to 14 for Tramadol group. TOTPAR scale ranges from 0 with no upper limit. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. This Secondary Endpoint is to evaluate the analgesic efficacy of Dexketoprofen/Tramadol fixed combination versus Tramadol 100 mg after the first 4 h intake during Single Dose Phase. Placebo arms measurement are not applicable since, as per outcome measure title above, this outcome measure was compared only between active arms | Posted | | Mean | Standard Deviation | score on a scale | | From t=o to T=4 hours | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours |
|
| Secondary | Total Pain Relief (TOTPAR) at 6h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol | TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 24 for Dexketoprofen/Tramadol group and 0 to 19 for Tramadol group. TOTPAR scale ranges from 0 with no upper limit. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. | Posted | | Mean | Standard Deviation | score on a scale | | T=0 to T=6h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours | | OG001 | Tramadol Hydrochloride 100 mg Treatment |
|
| Secondary | Total Pain Relief (TOTPAR) at 8h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol | TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 31 for Dexketoprofen/Tramadol group and 0 to 26 for Tramadol group. TOTPAR scale ranges from 0 with no upper limit. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. | Posted | | Mean | Standard Deviation | score on a scale | | From T=0 to T=8h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours | | OG001 | Tramadol Hydrochloride 100 mg Treatment |
|
| Secondary | Total Pain Relief (TOTPAR) at 6h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo | TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 24 for Dexketoprofen/Tramadol group and 0 to 23 for Placebo group. TOTPAR scale ranges from 0 with no upper limit. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. This Secondary Endpoint is to evaluate the analgesic efficacy of Dexketoprofen/Tramadol fixed combination versus placebo after the first dose (first 6 h) in the Single Dose Phase. Tramadol 100 mg Arm measurement is not applicable since, as per outcome measure title above, this outcome measure was compared only between Dexketoprofen/Tramadol and Placebo | Posted | | Mean | Standard Deviation | score on a scale | | From T=0 to T=6h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours |
|
| Secondary | Total Pain Relief (TOTPAR) at 8h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo | TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 31 for Dexketoprofen/Tramadol group and 0 to 27 for Placebo group. TOTPAR scale ranges from 0 with no upper limit. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio.This Secondary Endpoint is to evaluate the analgesic efficacy of Dexketoprofen/Tramadol fixed combination versus placebo after the first dose (first 8 h) in the Single Dose Phase. Tramadol 100 mg Arm measurement is not applicable since, as per outcome measure title above, this outcome measure was compared only between Dexketoprofen/Tramadol and Placebo | Posted | | Mean | Standard Deviation | score on a scale | | Form T=0 to T=8h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours |
|
| Secondary | Percentage of Maximum TOTPAR (%Max TOTPAR) at 4 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol | Max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR), were calculated at prespecified time points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 97 and 0 to 84 respectively for Dexketoprofen/Tramadol and Tramadol group. %max TOTPAR scale ranges from 0 to 100. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. This Secondary Endpoint is to evaluate the analgesic efficacy of Dexketoprofen/ Tramadol fixed combination versus Tramadol 100 mg after the first dose (first 4 h) in the Single Dose Phase. Placebo arms measurement are not applicable since, as per outcome measure title above, this outcome measure was compared only between active arms | Posted | | Mean | Standard Deviation | percentage of score on a scale | | Form T=0 to T=4h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | |
|
| Secondary | Percentage of Maximum TOTPAR (%Max TOTPAR) at 6 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol | Max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 98 for Dexketoprofen/Tramadol group and 0 to 77 for Tramadol group. %max TOTPAR scale ranges from 0 to 100. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. | Posted | | Mean | Standard Deviation | Percentage of score on a scale | | Form T=0 to T=6h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours |
|
| Secondary | Percentage of Maximum TOTPAR (%Max TOTPAR) at 8 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol | The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 98 for Dexketoprofen/Tramadol group and 0 to 83 for Tramadol group. %max TOTPAR scale ranges from 0 to 100. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. | Posted | | Mean | Standard Deviation | Percentage of score on a scale | | Form T=0 to T=8h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours |
|
| Secondary | Percentage of Maximum TOTPAR (%Max TOTPAR) at 6 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Placebo | The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 98 for Dexketoprofen/Tramadol group and 0 to 94 for Placebo group. %max TOTPAR scale ranges from 0 to 100. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio.This Secondary Endpoint is to evaluate the analgesic efficacy of Dexketoprofen/ Tramadol fixed combination versus placebo after the first dose (first 6 h) in the Single Dose Phase. Tramadol 100 mg Arm measurement is not applicable since, as per outcome measure title above, this outcome measure was compared only between Dexketoprofen/Tramadol and Placebo | Posted | | Mean | Standard Deviation | Percentage of score on a scale | | Form T=0 to T=6h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | |
|
| Secondary | Percentage of Maximum TOTPAR (%Max TOTPAR) at 8 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Placebo | The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 98 for Dexketoprofen/Tramadol group and 0 to 83 for Placebo group. %max TOTPAR scale ranges from 0 to 100. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio.This Secondary Endpoint is to evaluate the analgesic efficacy of Dexketoprofen/Tramadol fixed combination versus placebo after the first dose (first 8 h) in the Single Dose Phase. Tramadol 100 mg Arm measurement is not applicable since, as per outcome measure title above, this outcome measure was compared only between Dexketoprofen/Tramadol and Placebo | Posted | | Mean | Standard Deviation | Percentage score on a scale | | Form T=0 to T=8h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | |
|
| Secondary | Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 4 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol | | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. | Posted | | Number | | percentage of patients | | Form T=0 to T=4h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours | | OG001 | Tramadol Hydrochloride 100 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase (administered as 2 capsules of Tramadol 50 mg) Tramadol Hydrochloride 100 mg: Administered as two capsules with 50 mg each to be taken every 8 hours |
| |
| Secondary | Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 6 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol | | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. | Posted | | Number | | percentage of patients | | Form T=0 to T=6h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours | | OG001 | Tramadol Hydrochloride 100 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase (administered as 2 capsules of Tramadol 50 mg) Tramadol Hydrochloride 100 mg: Administered as two capsules with 50 mg each to be taken every 8 hours |
| |
| Secondary | Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 8 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol | | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. | Posted | | Number | | percentage of patients | | Form T=0 to T=8h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours | | OG001 | Tramadol Hydrochloride 100 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase (administered as 2 capsules of Tramadol 50 mg) Tramadol Hydrochloride 100 mg: Administered as two capsules with 50 mg each to be taken every 8 hours |
| |
| Secondary | Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 4 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo | TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at pre-specified time point points in the single and the multiple-dose phases of the study. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio.This Secondary Endpoint is to evaluate the analgesic efficacy of Dexketoprofen Trometamol 25 mg/ Tramadol Hydrochloride 75 mg fixed combination versus placebo after the first dose (first 6 h) in the Single Dose Phase. Tramadol Hydrochloride 100 mg Arm is not reported since data of patients in that Arm are not analyzed for this Endpoint | Posted | | Number | | percentage of patients | | Form T=0 to T=4h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours |
|
| Secondary | Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 6 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo | TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at pre specified time point points in the single and the multiple-dose phases of the study. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio.This Secondary Endpoint is to evaluate the analgesic efficacy of Dexketoprofen Trometamol 25 mg/ Tramadol Hydrochloride 75 mg fixed combination versus placebo after the first dose (first 6 h) in the Single Dose Phase. Tramadol Hydrochloride 100 mg Arm is not reported since data of patients in that Arm are not analyzed for this Endpoint | Posted | | Number | | percentage of patients | | Form T=0 to T=6h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours |
|
| Secondary | Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 8 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo | TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at pre specified time point points in the single and the multiple-dose phases of the study. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio.This Secondary Endpoint is to evaluate the analgesic efficacy of Dexketoprofen Trometamol 25 mg/ Tramadol Hydrochloride 75 mg fixed combination versus placebo after the first dose (first 6 h) in the Single Dose Phase. Tramadol Hydrochloride 100 mg Arm is not reported since data of patients in that Arm are not analyzed for this Endpoint | Posted | | Number | | percentage of patients | | Form T=0 to T=8h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours |
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| Secondary | Total Pain Relief (TOTPAR) at 24h After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol | TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 96 for Dexketoprofen/Tramadol group and 0 to 90 for Tramadol group. TOTPAR scale ranges from 0 with no upper limit. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. | Posted | | Mean | Standard Deviation | score on a scale | | Form T=0 to T=24h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours | | OG001 |
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| Secondary | Total Pain Relief (TOTPAR) at 48h After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol | TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 192 for Dexketoprofen/Tramadol group and 0 to 184 for Tramadol group. TOTPAR scale ranges from 0 with no upper limit. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. | Posted | | Mean | Standard Deviation | score on a scale | | Form T=0 to T=48h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours | | OG001 |
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| Secondary | Total Pain Relief (TOTPAR) at 72h After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol | TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 288 for Dexketoprofen/Tramadol group and 0 to 280 for Tramadol group. TOTPAR scale ranges from 0 with no upper limit. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. | Posted | | Mean | Standard Deviation | score on a scale | | Form T=0 to T=72h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours | | OG001 |
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| Secondary | Percentage of Maximum TOTPAR (%Max TOTPAR) at 24 Hours After the First Dose- Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol | The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 100 for Dexketoprofen/Tramadol group and 0 to 94 for Tramadol group. %max TOTPAR scale ranges from 0 to 100. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. | Posted | | Mean | Standard Deviation | Percentage of score on a scale | | Form T=0 to T=24h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours |
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| Secondary | Percentage of Maximum TOTPAR (%Max TOTPAR) at 48 Hours After the First Dose- Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol | The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 100 for Dexketoprofen/Tramadol group and 0 to 96 for Tramadol group. %max TOTPAR scale ranges from 0 to 100. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. | Posted | | Mean | Standard Deviation | Percentage of score on a scale | | Form T=0 to T=48h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours |
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| Secondary | Percentage of Maximum TOTPAR (%Max TOTPAR) at 72 Hours After the First Dose- Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol | The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 100 for Dexketoprofen/Tramadol group and 0 to 97 for Tramadol group. %max TOTPAR scale ranges from 0 to 100. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. | Posted | | Mean | Standard Deviation | Percentage of score on a scale | | Form T=0 to T=72h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours |
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| Secondary | Percentage of Maximum TOTPAR (%Max TOTPAR) at 96 Hours After the First Dose- Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol | The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 100 for Dexketoprofen/Tramadol group and 0 to 98 for Tramadol group. %max TOTPAR scale ranges from 0 to 100. | The modified intent-to-treat (mITT) population included the first cohort of patients randomized to the 4 treatment arms in a 4:4:1:1 ratio. | Posted | | Mean | Standard Deviation | Percentage of score on a scale | | Form T=0 to T=96h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg: Administered as one single tablet to be taken every 8 hours |
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| Secondary | Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 48 Hours After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol | TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at pre-specified time point points in the single and the multiple-dose phases of the study. | Per-protocol (PP) population included all patients in the ITT having major protocol violations that could affect the primary efficacy analysis. Protocol violations which had a major distorting influence on the primary endpoints resulted in patients being excluded from the PP population. Protocol Deviations identified during the the study conduct, as authorized in the final Protocol Deviation log, were taken into consideration in the final assignment of patients to the analysis sets. | Posted | | Number | | Percentage of patients | | Form T=0 to T=48h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | All patients receiving DexketoprofenTrometamol 25 mg/Tramadol Hydrochloride 75 mg fixed combination. This arm present combined data value from DexketoprofenTrometamol 25 mg/Tramadol Hydrochloride 75 mg arm and from Placebo then Dexketoprofen Trometamol 25mg/Tramadol Hydrochloride 75 mg arm. |
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| Secondary | Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 72 Hours After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol | The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some(meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR),percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at pre specified time point points in the single and the multiple-dose phases of the study. | Per-protocol (PP) population included all patients in the ITT having major protocol violations that could affect the primary efficacy analysis. Protocol violations which had a major distorting influence on the primary endpoints resulted in patients being excluded from the PP population. Protocol Deviations identified during the the study conduct, as authorized in the final Protocol Deviation log, were taken into consideration in the final assignment of patients to the analysis sets. | Posted | | Number | | Percentage of patients | | Form T=0 to T=72h | | | | ID | Title | Description |
|---|
| OG000 | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg Treatment | All patients receiving Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg fixed combination. This arm present combined data value from Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg arm and from Placebo then Dexketoprofen Trometamol 25mg/Tramadol Hydrochloride 75 mg arm. |
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