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| ID | Type | Description | Link |
|---|---|---|---|
| R331333PAI3035 | Other Identifier | Janssen-Cilag International NV |
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| Name | Class |
|---|---|
| Grünenthal GmbH | INDUSTRY |
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The purpose of this study is to evaluate the analgesic efficacy and safety of tapentadol immediate-release (IR [CG5503]) for use in the relief of moderate to severe acute pain, compared with placebo, in adult Taiwanese patients with acute pain following bunionectomy.
Patients undergoing bunionectomy (a surgical procedure to remove a bunion, an enlargement of the joint at the base of the big toe comprised of bone and soft tissue) often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when patients receive repeated doses of opioid analgesics. Tapentadol (CG5503) is a newly synthesized opioid drug acting as a centrally acting analgesic like opioid analgesics but has a different mode of action. This study, a randomized (patients are assigned different treatments based on chance), double-blind (neither investigator nor patient knows which treatment the patient receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each group of patients will be treated at the same time), multicenter study (the study is performed at more than one clinic) is designed to evaluate the effectiveness (level of pain control) and safety (side effects) of tapentadol immediate-release (IR) 50 mg or 75 mg versus placebo. The study will consist of a screening phase, during which the patients will be evaluated for study entry (Days -28 to -2) followed by the surgical period (Day -1) during which the bunionectomy will be performed and which will start with the first surgical incision and continues until termination of the popliteal sciatic block (PSB) infusion. During the qualification period (Day 1) which starts after termination of the post-operative continuous PSB infusion, patients will be evaluated for entry in the double blind treatment phase. Patients will be randomly assigned to one of three treatment groups to receive either 50 mg tapentadol IR, 75 mg tapentadol IR or a placebo if their PI is equal to or greater than 4 on a 0-10 numerical rating scale. The inpatient double-blind treatment period will be 72 hours in duration and will include a final end-of-double-blind evaluation (on Day 4, i.e., 72 hours after the administration of the first dose) for all patients. Any patient requiring analgesia for pain relief in addition to study drug during the double-blind treatment period will be discontinued from the study due to lack of efficacy. All patients who discontinue for lack of efficacy will complete pain assessments and the Patient Global Impression of Change (PGIC) before receiving rescue medication. Pain intensity and pain relief will be periodically assessed during the treatment period using rating scales. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. The study length, including the screening period, will be up to a maximum duration of 32 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tapentadol IR 50 mg | Experimental |
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| Tapentadol IR 75 mg | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tapentadol IR 50 mg | Drug | Tapentadol IR 50 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Difference (SPID) Over 48 Hours | Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Rescue Medication Use | Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants. | up to 48 hours |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung City | Taiwan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26293513 | Derived | Chen YJ, Chiang CC, Huang PJ, Huang J, Karcher K, Li H. Tapentadol immediate-release for acute postbunionectomy pain: a phase 3, randomized, double-blind, placebo-controlled, parallel-group study in Taiwan. Curr Med Res Opin. 2015 Nov;31(11):2001-9. doi: 10.1185/03007995.2015.1082992. Epub 2015 Sep 21. |
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The study was conducted from 11 January 2013 to 12 January 2014. Participants were recruited at 3 study centers in Taiwan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days. |
| FG001 | Tapentadol IR 50 mg | Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Tapentadol IR 75 mg | Drug | Tapentadol IR 75 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period. |
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| Placebo | Drug | Placebo will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period. |
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| Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours |
Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent. |
| 12, 24, 48 and 72 hours |
| Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours | Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent. | 12, 24, 48 and 72 hours |
| Sum of Pain Intensity Differences (SPID) Over 12, 24 and 72 Hours | Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief. | 12, 24 and 72 hours |
| Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours | Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief. | 12, 24, 48, and 72 hours |
| Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours | Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief. | 12, 24, 48 and 72 hours |
| Patient Global Impression of Change (PGI-C) Score at 72 Hours | The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening. | Baseline (Day 1) and 72 hours |
| Taipei |
| Taiwan |
| Taoyuan | Taiwan |
| FG002 | Tapentadol IR 75 mg | Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days. |
| BG001 | Tapentadol IR 50 mg | Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days. |
| BG002 | Tapentadol IR 75 mg | Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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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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| Age Customized | Number | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sum of Pain Intensity Difference (SPID) Over 48 Hours | Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief. | Intent-to-treat (ITT) analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values. | Posted | Mean | Standard Deviation | units on a scale | 48 hours |
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| Secondary | Time to First Rescue Medication Use | Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants. | ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. | Posted | Median | Inter-Quartile Range | Hours | up to 48 hours |
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| Secondary | Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours | Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent. | ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. | Posted | Number | Percentage of Participants | 12, 24, 48 and 72 hours |
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| Secondary | Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours | Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent. | ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. | Posted | Number | Percentage of Participants | 12, 24, 48 and 72 hours |
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| Secondary | Sum of Pain Intensity Differences (SPID) Over 12, 24 and 72 Hours | Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief. | ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values. | Posted | Mean | Standard Deviation | units on a scale | 12, 24 and 72 hours |
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| Secondary | Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours | Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief. | ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values. | Posted | Mean | Standard Deviation | units on a scale | 12, 24, 48, and 72 hours |
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| Secondary | Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours | Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief. | ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values. | Posted | Mean | Standard Deviation | units on a scale | 12, 24, 48 and 72 hours |
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| Secondary | Patient Global Impression of Change (PGI-C) Score at 72 Hours | The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening. | ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values. | Posted | Number | Percentage of participants | Baseline (Day 1) and 72 hours |
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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) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days. | 0 | 20 | 3 | 20 | ||
| EG001 | Tapentadol IR 50 mg | Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days. | 0 | 21 | 19 | 21 | ||
| EG002 | Tapentadol IR 75 mg | Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days. | 0 | 19 | 18 | 19 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 16.1 | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA Version 16.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 16.1 | Non-systematic Assessment |
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| Wound complication | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 16.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 16.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Version 16.1 | Non-systematic Assessment |
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| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mila Etropolski, Clinical Leader | Janssen Research & Development, L.L.C. | 609-730-4537 | MEtropol@its.jnj.com |
| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| D059787 | Acute Pain |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| Male |
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| Greater than or equal (>=) to 65 years |
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Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group
| No |
| Superiority or Other |
| Based on participant availability in Taiwan it was expected that 60 subjects (20 per group) would be enrolled. In consultation with the Taiwan health authority, the overall two-sided significance level was set at 0.20 (0.10 for each tapentadol versus placebo comparison). Assuming a standard deviation of 134.4, this sample size would provide 71.5% power to detect a between-group difference in SPID48 of 94.1 and 81.2% power to detect a between-group difference of 107.52. | ANCOVA | ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate. | 0.004 | P-value adjusted for multiple treatment group comparisons using the Hochberg method. | Median Difference (Net) | 126.58 | 2-Sided | 95 | 49.5 | 203.7 | Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group. | No | Superiority or Other |
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| OG002 |
| Tapentadol IR 75 mg |
Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days. |
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| Units | Counts |
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