A Phase 3 interventional study of Tapentadol IR 50 mg and Tapentadol IR 75 mg in Hallux Valgus, sponsored by Janssen-Cilag International NV. Completed at 3 sites in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-01-09.
Sponsored by Janssen-Cilag International NV · Phase 3, Interventional, and Treatment
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.
144 studies on the registry are indexed under Hallux Valgus; 31 are open to participants now.
This study's enrollment of 60 is close to the median of 56 across 106 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Janssen-Cilag International NV is the lead sponsor of 66 studies on the registry; none are open to participants now.
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Inclusion Criteria:
Drug: Tapentadol IR 50 mg
Drug: Tapentadol IR 75 mg
Drug: Placebo
Tapentadol IR 50 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.
Tapentadol IR 75 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.
Placebo will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.
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.
Time frame: 48 hours
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.
Time frame: up to 48 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 1) and 72 hours
The study was conducted from 11 January 2013 to 12 January 2014. Participants were recruited at 3 study centers in Taiwan.
| Milestone | Placebo | Tapentadol IR 50 mg | Tapentadol IR 75 mg |
|---|---|---|---|
| Started | 20 | 21 | 19 |
| Completed | 11 | 17 | 13 |
| Not completed | 9 | 4 | 6 |
| Withdrew: Adverse event | 0 | 3 | 4 |
| Withdrew: Lack of efficacy | 9 | 1 | 2 |
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.
| units on a scale | Placebo | Tapentadol IR 50 mg | Tapentadol IR 75 mg |
|---|---|---|---|
| Sum of Pain Intensity Difference (SPID) Over 48 Hours | 50.8 ± 158.52 | 168.4 ± 84.50 | 194.9 ± 131.13 |
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.
| Hours | Placebo | Tapentadol IR 50 mg | Tapentadol IR 75 mg |
|---|---|---|---|
| Time to First Rescue Medication Use | NA ± 84.50 | NA ± 131.13 | NA ± 158.52 |
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.
| Percentage of Participants | Placebo | Tapentadol IR 50 mg | Tapentadol IR 75 mg |
|---|---|---|---|
| 12 hours | 35.0 | 66.7 | 73.7 |
| 24 hours | 40.0 | 66.7 | 73.7 |
| 48 hours | 45.0 | 81.0 | 68.4 |
| 72 hours | 45.0 | 81.0 | 68.4 |
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.
| Percentage of Participants | Placebo | Tapentadol IR 50 mg | Tapentadol IR 75 mg |
|---|---|---|---|
| 12 hours | 20.0 | 42.9 | 57.9 |
| 24 hours | 35.0 | 61.9 | 73.7 |
| 48 hours | 40.0 | 76.2 | 68.4 |
| 72 hours | 45.0 | 81.0 | 68.4 |
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.
| units on a scale | Placebo | Tapentadol IR 50 mg | Tapentadol IR 75 mg |
|---|---|---|---|
| 12 hours | 7.6 ± 32.22 | 30.3 ± 17.24 | 34.7 ± 25.70 |
| 24 hours | 16.7 ± 69.37 | 67.5 ± 40.90 | 82.0 ± 57.65 |
| 72 hours | 91.6 ± 252.89 | 281.3 ± 129.48 | 316.1 ± 206.81 |
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.
| units on a scale | Placebo | Tapentadol IR 50 mg | Tapentadol IR 75 mg |
|---|---|---|---|
| 12 hours | 13.0 ± 11.29 | 22.5 ± 10.27 | 24.4 ± 10.33 |
| 24 hours | 28.0 ± 24.50 | 48.2 ± 22.07 | 54.1 ± 20.47 |
| 48 hours | 68.2 ± 62.26 | 115.6 ± 45.06 | 123.5 ± 49.99 |
| 72 hours | 112.6 ± 103.19 | 187.3 ± 68.03 | 194.1 ± 74.63 |
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.
| units on a scale | Placebo | Tapentadol IR 50 mg | Tapentadol IR 75 mg |
|---|---|---|---|
| 12 hours | 20.7 ± 41.51 | 52.8 ± 25.66 | 59.1 ± 33.20 |
| 24 hours | 44.7 ± 90.14 | 115.7 ± 59.74 | 136.0 ± 72.59 |
| 48 hours | 119.1 ± 214.14 | 284.0 ± 122.07 | 318.4 ± 171.50 |
| 72 hours | 204.3 ± 346.52 | 468.6 ± 185.43 | 510.2 ± 268.96 |
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.
| Percentage of participants | Placebo | Tapentadol IR 50 mg | Tapentadol IR 75 mg |
|---|---|---|---|
| Very Much Improved | 40.0 | 71.4 | 73.7 |
| Much Improved | 10.0 | 14.3 | 5.3 |
| Minimally Improved | 5.0 | 9.5 | 10.5 |
| No Change | 20.0 | 4.8 | 0.0 |
| Minimally Worse | 0.0 | 0.0 | 0.0 |
| Much Worse | 0.0 | 0.0 | 0.0 |
| Very Much Worse | 25.0 | 0.0 | 10.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/20 (0%) | 3/20 (15%) |
| Tapentadol IR 50 mg | — | 0/21 (0%) | 19/21 (90.5%) |
| Tapentadol IR 75 mg | — | 0/19 (0%) | 18/19 (94.7%) |
| Event | Placebo | Tapentadol IR 50 mg | Tapentadol IR 75 mg |
|---|---|---|---|
| DizzinessNervous system disorders | 1/20 | 14/21 | 16/19 |
| VomitingGastrointestinal disorders | 0/20 | 4/21 | 10/19 |
| NauseaGastrointestinal disorders | 1/20 | 7/21 | 8/19 |
| PyrexiaGeneral disorders | 2/20 | 3/21 | 2/19 |
| HeadacheNervous system disorders | 1/20 | 3/21 | 2/19 |
| SomnolenceNervous system disorders | 0/20 | 3/21 | 2/19 |
| Wound complicationInjury, poisoning and procedural complications | 0/20 | 2/21 | 0/19 |
| Chest discomfortGeneral disorders | 0/20 | 0/21 | 1/19 |
| PruritusSkin and subcutaneous tissue disorders | 0/20 | 0/21 | 1/19 |
| RashSkin and subcutaneous tissue disorders | 0/20 | 0/21 | 1/19 |
| Age, Continuous(years) | Placebo | Tapentadol IR 50 mg | Tapentadol IR 75 mg | Total |
|---|---|---|---|---|
| Mean | 44.4 ± 14.98 | 42.3 ± 14.27 | 43.3 ± 11.81 | 43.3 ± 13.59 |
| Sex: Female, Male(Participants) | Placebo | Tapentadol IR 50 mg | Tapentadol IR 75 mg | Total |
|---|---|---|---|---|
| Female | 19 | 21 | 18 | 58 |
| Male | 1 | 0 | 1 | 2 |
| Age Customized(participants) | Placebo | Tapentadol IR 50 mg | Tapentadol IR 75 mg | Total |
|---|---|---|---|---|
| Less than (<) 65 years | 18 | 20 | 18 | 56 |
| Greater than or equal (>=) to 65 years | 2 | 1 | 1 | 4 |
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Janssen-Cilag International NV