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| ID | Type | Description | Link |
|---|---|---|---|
| TRAMAPPAI3005 |
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The purpose of this study is to compare the efficacy and safety of extended release (ER) tramadol hydrochloride (HCl)/acetaminophen with immediate release (IR) tramadol HCl/acetaminophen in participants with moderate to severe (very serious, life threatening) postoperative pain.
This study is a randomized (study drug assigned by chance), multicenter (when more than 1 hospital or medical school team work on a medical research study), active-controlled, parallel group (each group of participants will be treated at the same time), double-blind (neither physician nor participant knows the treatment that the participant receives) study. The duration of the treatment will be 2 days and will be conducted in 4 periods: screening period (from 33 to 2 days before study drug administration to the first surgical incision), surgical period (to 1 day before study drug administration), qualification period (1 day) and double-blind treatment period (1 to 2 days). Participants will be randomly assigned to 2 groups: study drug treatment group (ER) and comparator treatment group (IR). Participants will be administered 2 tablets of ER tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) along with 2 tablets of placebo matching to IR tramadol HCl/acetaminophen in study drug treatment group; and 2 tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) along with 2 tablets of placebo matching to ER tramadol HCl/acetaminophen in comparator treatment group respectively at 0, 12, 24 and 36 hours. Participants will also be administered 2 tablets of placebo matching to IR tramadol HCl/acetaminophen in study drug treatment group; and 2 tablets of IR tramadol HCl/acetaminophen in comparator treatment group respectively at 6, 18, 30 and 42 hours. Participants will be administered investigational product at 6-hour interval from the time of the first investigational product administration over 48 hours. Efficacy will be assessed using 11-point numeric rating scale (NRS). Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol Hydrochloride/Acetaminophen ER | Experimental | Participants will be administered 2 oral tablets of extended release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matching to immediate release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matching to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours. |
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| Tramadol HCl/Acetaminophen IR | Active Comparator | Participants will be administered 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matching to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol HCl/Acetaminophen ER | Drug | 2 tablets of ER (tramadol HCl [75 mg]/acetaminophen [650 mg]) will be administered at 0, 12, 24 and 36 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Difference (SPID) at Hour 48 | The SPID is time-weighted sum of all observations of pain intensity difference (PID) collected at each measurement time point from Baseline to 48 hours. PID: Baseline pain intensity (PI) minus current PI; PI was assessed using 11-point numeric rating scale (NRS, 0=no pain to 10=worst pain imaginable). PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <=3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. Total score for SPID at 48 hours (SPID48) ranges from -144 (worst) to 144 (best). | Hour 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Difference (SPID) at Hour 6, 12 and 24 | The SPID is time-weighted sum of all observations of PID collected at each measurement time point from Baseline to 24 hours. PID: Baseline PI minus current PI; PI was assessed using 11-point NRS, 0=no pain to 10=worst pain imaginable. PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <=3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. Total score ranges from -18 (worst) to 18 (best) for SPID6, -36 (worst) to 36 (best) for SPID12 and -72 (worst) to 72 (best) for SPID24. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea Ltd. Clinical Trial | Janssen Korea Ltd. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25299350 | Derived | Park YB, Ha CW, Cho SD, Lee MC, Lee JH, Seo SS, Kang SB, Kyung HS, Choi CH, Chang N, Rhim HY, Bin SI. A randomized study to compare the efficacy and safety of extended-release and immediate-release tramadol HCl/acetaminophen in patients with acute pain following total knee replacement. Curr Med Res Opin. 2015 Jan;31(1):75-84. doi: 10.1185/03007995.2014.975338. Epub 2014 Oct 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tramadol Hydrochloride (HCl)/Acetaminophen ER | Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Tramadol HCl/Acetaminophen IR | Drug | 2 tablets of IR (tramadol HCl [37.5 mg]/acetaminophen [325 mg]) at 0, 6, 12, 18, 24, 30, 36 and 42 hours |
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| Hour 6, 12, 24 |
| Total Pain Relief (TOTPAR) Score | Pain relief was measured on a 5-point categorical scale of 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). TOTPAR was calculated as the time-weighted sum over all pain relief up to 48 hours. Total score ranges from 0 (worst) to 24 (best) for TOTPAR6, 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24 and 0 (worst) to 192 (best) for TOTPAR48. | Hour 6, 12, 24, 48 |
| Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) | The SPRID is sum of SPID and TOTPAR. In SPID, PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <= 3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. In TOTPAR, pain relief score ranges from 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). Total score ranges from -18 (worst) to 42 (best) for SPRID6, -36 (worst) to 84 (best) for SPRID12, -72 (worst) to 168 (best) for SPRID24 and -144 (worst) to 336 (best) for SPRID48. | Hour 6, 12, 24, 48 |
| Time to the First Rescue Medication Administered Because of Insufficient Pain Relief | The time until administration of the first rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief after administration of the study drug was recorded. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular [directly into muscle] or intravenous injection [directly into vein]). | Baseline up to Day 3 |
| Number of Doses of Rescue Medication Administered Because of Insufficient Pain Relief | The frequency of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection). | Baseline up to Day 3 |
| Dosage of Rescue Medication Administered Because of Insufficient Pain Relief | The dosage of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection). | Baseline up to Day 3 |
| Patient Global Impression of Change (PGIC) Score | The PGIC was used to assess the degree of participant's overall improvement with treatment, and participants were instructed to assess how much the overall status had been improved after investigational product administration compared to baseline in 7 grades (1=Very much improved and B=Very much worsened). | Day 3 |
| FG001 | Tramadol HCl/Acetaminophen IR | Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tramadol Hydrochloride (HCl)/Acetaminophen ER | Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours. |
| BG001 | Tramadol HCl/Acetaminophen IR | Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Sum of Pain Intensity Difference (SPID) at Hour 48 | The SPID is time-weighted sum of all observations of pain intensity difference (PID) collected at each measurement time point from Baseline to 48 hours. PID: Baseline pain intensity (PI) minus current PI; PI was assessed using 11-point numeric rating scale (NRS, 0=no pain to 10=worst pain imaginable). PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <=3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. Total score for SPID at 48 hours (SPID48) ranges from -144 (worst) to 144 (best). | The per-protocol (PP) population included all randomly assigned participants who did not violate major eligibility criteria and whose SPID was calculated with actual measurements or adjusted values at all assessment time points. | Posted | Mean | Standard Deviation | Units on scale | Hour 48 |
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| Secondary | Sum of Pain Intensity Difference (SPID) at Hour 6, 12 and 24 | The SPID is time-weighted sum of all observations of PID collected at each measurement time point from Baseline to 24 hours. PID: Baseline PI minus current PI; PI was assessed using 11-point NRS, 0=no pain to 10=worst pain imaginable. PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <=3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. Total score ranges from -18 (worst) to 18 (best) for SPID6, -36 (worst) to 36 (best) for SPID12 and -72 (worst) to 72 (best) for SPID24. | The intent-to-treat population included all randomly assigned participants. Here, 'N' (number of participants analyzed) specifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on scale | Hour 6, 12, 24 |
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| Secondary | Total Pain Relief (TOTPAR) Score | Pain relief was measured on a 5-point categorical scale of 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). TOTPAR was calculated as the time-weighted sum over all pain relief up to 48 hours. Total score ranges from 0 (worst) to 24 (best) for TOTPAR6, 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24 and 0 (worst) to 192 (best) for TOTPAR48. | The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on scale | Hour 6, 12, 24, 48 |
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| Secondary | Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) | The SPRID is sum of SPID and TOTPAR. In SPID, PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <= 3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. In TOTPAR, pain relief score ranges from 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). Total score ranges from -18 (worst) to 42 (best) for SPRID6, -36 (worst) to 84 (best) for SPRID12, -72 (worst) to 168 (best) for SPRID24 and -144 (worst) to 336 (best) for SPRID48. | The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on scale | Hour 6, 12, 24, 48 |
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| Secondary | Time to the First Rescue Medication Administered Because of Insufficient Pain Relief | The time until administration of the first rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief after administration of the study drug was recorded. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular [directly into muscle] or intravenous injection [directly into vein]). | The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Minutes | Baseline up to Day 3 |
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| Secondary | Number of Doses of Rescue Medication Administered Because of Insufficient Pain Relief | The frequency of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection). | The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Doses | Baseline up to Day 3 |
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| Secondary | Dosage of Rescue Medication Administered Because of Insufficient Pain Relief | The dosage of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection). | The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Milligram | Baseline up to Day 3 |
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| Secondary | Patient Global Impression of Change (PGIC) Score | The PGIC was used to assess the degree of participant's overall improvement with treatment, and participants were instructed to assess how much the overall status had been improved after investigational product administration compared to baseline in 7 grades (1=Very much improved and B=Very much worsened). | The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on scale | Day 3 |
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Screening up to Day 3 or early withdrawal
Safety population included all participants who received at least 1 dose of study drug. Number of participants evaluable for safety was 161 in Tramadol Hydrochloride/Acetaminophen ER arm and 153 in Tramadol HCl/Acetaminophen IR arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Tramadol Hydrochloride (HCl)/Acetaminophen ER | Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours. | 1 | 161 | 139 | 161 | ||
| EG001 | Tramadol HCl/Acetaminophen IR | Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours. | 0 | 153 | 129 | 153 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Deep vein thrombosis | Vascular disorders | MedDRA Version 13.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Constipation | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 13.1 | Non-systematic Assessment |
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| Wound secretion | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
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Principal Investigator (PI) cannot provide any trial related information to external parties' without mutual agreement with the Sponsor. This is valid even after the contract is cancelled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Director | Janssen Korea/25F, LS Yongsan Tower, 191 Hankangro 2-Ga, Yongsan-Gu, Seoul 140-702, Korea | 82-2-2094-4518 |
| ID | Term |
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| D010149 | Pain, Postoperative |
| ID | Term |
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
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| C478659 | Ultracet |
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