| Primary | Percentage of Participants With Reduction in Pain Intensity | The percentage of participants with extent of reduction in pain intensity greater than or equal to 30 percent was reported. Pain intensity change rate was calculated by Visual Analog Scale (VAS) score at baseline minus VAS score at Day 29 divided by VAS score at Baseline. VAS is a 10 centimeter (cm) scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain. | Full analysis set (FAS) population included all participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Baseline up to Day 29 | | | | ID | Title | Description |
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| OG000 | Tramadol HCl/Acetaminophen | Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. | | OG001 | Placebo | Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00057.65(47.14 to 68.15)
- OG00141.11(30.95 to 51.28)
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| | 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 |
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| | Cochran-Mantel-Haenszel | p-value for percentage of participants with reduction in pain intensity was calculated for tramadol HCl/acetaminophen and placebo groups | 0.0367 | | | | | | | | | | | | | No | Superiority or Other | | |
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| Primary | Change From Baseline in Pain Intensity at Day 29 | Change in pain intensity experienced by participants over the last 48 hours was measured on Day 29 against Baseline with VAS. VAS is a 10 cm scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain. | The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. | Posted | | Mean | Standard Deviation | Unit on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
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| OG000 | Tramadol HCl/Acetaminophen | Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. | | OG001 | Placebo | Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. |
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| Secondary | Percentage of Participants With Pain Relief | Pain relief was measured in 6 stages to assess the participant's pain relief. Extent of pain relief was measured on a scale ranging from 4 to -1, where 4=complete disappearance, 3=fair relief, 2=moderate relief, 1=slight relief, 0=no change and -1=pain worsening. Relief more than 'slight relief (1)' was considered as pain relief success. | the FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 8, Day 15 and Day 29 | | | | ID | Title | Description |
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| OG000 | Tramadol HCl/Acetaminophen | Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. | | OG001 | Placebo | Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. |
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| Secondary | Change From Baseline in Short Form (SF)-36 Score at Day 29 | The quality of life of participants was evaluated by SF-36 Korean version questionnaire. It is composed of 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Participants answered to the questionnaire of 36 questions; and physical, social, and psychological health status were assessed. It ranges 0 to 100, and higher score indicates better quality of life, But in "Reported (Rptd.) Health Transition" domain higher score indicates worse quality of life. | The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. | Posted | | Mean | Standard Deviation | Unit on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
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| OG000 | Tramadol HCl/Acetaminophen | Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. | | OG001 | Placebo | Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. |
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| Secondary | Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29 | The ODI Korean version was used to assess the participant's functionality. The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). Total score is the sum of score obtained in each section and ranges from 0 to 50. A higher score represents greater disability. | FAS population included all participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. | Posted | | Mean | Standard Deviation | Unit on a scale | | Baseline and Day 29 | | | | ID | Title | Description |
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| OG000 | Tramadol HCl/Acetaminophen | Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. | | OG001 | Placebo | Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. |
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| Secondary | Percentage of Participants With Investigator's Global Assessment on Investigational Product | Global assessment on investigational product was done by investigator on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than "Good" was considered as pain improvement success. Percentage of participants with pain improvement success is reported here. | The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. Here 'N' signifies those participants who were evaluated for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Tramadol HCl/Acetaminophen | Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. | | OG001 | Placebo | Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. |
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| Secondary | Percentage of Participants With Participants' Global Assessment on Investigational Product | Global assessment on investigational product was done by participants on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than "Good" was considered as pain improvement success. Percentage of participants with pain improvement success is reported here. | The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. Here 'N' signifies those participants who were evaluated for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 29 | | | | ID | Title | Description |
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| OG000 | Tramadol HCl/Acetaminophen | Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. | | OG001 | Placebo | Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28. |
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