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Abstracts (744) Efficacy and safety of lumiracoxib 400 mg compared to celecoxib 400 mg or placebo for treatment of pain following dental surgery J Fricke, N Davis, V Yu, G Krammer; PPD Dental Research Clinic, Austin, TX Lumiracoxib, a potent selective COX 2 inhibitor, has been shown to be rapid acting, effective and well tolerated in patients with post-operative dental pain. This single-center, randomized, double-blind, parallelgroup study evaluated the analgesic effect of single doses of lumiracoxib 400 mg, celecoxib 400 mg and placebo in the treatment of postdental surgery pain in patients who experience moderate to severe pain after the extraction of two or more partially impacted or fully bony impacted molars. A total of 364 patients (aged 18-52 years) were randomized (3:3:1) to treatment with single oral doses of lumiracoxib 400 mg (n⫽156), celecoxib 400 mg (n⫽156) or placebo (n⫽52). The primary efficacy variable was summed (time-weighted) pain intensity difference (categorical scale) calculated over the first 8 hours post-dose time period (SPID-8). Lumiracoxib was statistically superior to celecoxib for SPID-8 (estimated treatment difference: 4.05 [95% CI: 2.33, 5.78]; p⬍0.001). For the secondary efficacy variable, time-specific pain intensity difference (PID) based on the categorical scale over 0-24 hours, lumiracoxib showed statistically significantly higher levels of analgesia from 30 minutes until 12 hours post-dose compared to celecoxib and from 30 minutes to 24 hours compared to placebo. Additionally, lumiracoxib demonstrated the longest (12.13 hrs) median time-to-first-rescue medication intake compared with celecoxib (3.8 hrs) and placebo (1.28 hrs). In the patient global evaluation assessments, 28.8% of patients evaluated treatment with lumiracoxib as excellent while 18.6% and 1.9% evaluated celecoxib and placebo respectively as excellent. The incidence of adverse events was comparable between treatments (11.5% for lumiracoxib,10.9% for celecoxib and 17.3% for placebo) and there were no serious adverse events or discontinuations due to adverse events. These results demonstrate that a single dose of lumiracoxib 400 mg is well tolerated and provides rapid, effective, sustained relief from postoperative dental pain.
S37 (746) Effects of extended-release tramadol on osteoarthritis pain in the elderly J Xiang, M Siccardi, C Janagap, G Vorsanger; Ortho-McNeil Janssen Scientific Affairs, Raritan, NJ Given once daily, extended-release (ER) tramadol HCl (ULTRAM® ER) reduces pain and related symptoms of osteoarthritis (OA). Two 12-week, double-blind, placebo-controlled, randomized, parallel-group studies were conducted to compare the analgesic efficacy, safety, and tolerability of tramadol ER (100, 200, 300, and 400 mg for Study A and 100, 200, and 300 mg for Study B) as compared to placebo in patients (20-80 years) with moderate-to-severe pain due to radiographically-confirmed OA of the knee or hip (Study A, N⫽1020; Study B, N⫽1011). This post-hoc analysis evaluated tramadol ER in patients ⱖ65 years (n⫽556) from both studies. Patients rated their arthritis pain utilizing a 100-mm (0⫽no pain, 100⫽extreme pain) visual analog scale (VAS); pain and related symptoms were assessed using the WOMAC OA index. Sleep effects were evaluated using the Chronic Pain Sleep Inventory scores based on a 100-mm VAS (0⫽never, 100⫽always). From baseline to Week 12, this analysis demonstrated: a significant improvement in the pain, physical function, and joint stiffness subscales of the WOMAC OA index and the composite score, and pain intensity VAS scores in the index and nonindex joints for the tramadol ER 300-mg group (P ⱕ0.035 vs placebo); a significant decrease in awakening by pain at night and trouble falling asleep (100-, 200-, 300-mg groups); a significant decrease in awakening by pain in the morning (200- and 300-mg groups); and significantly better sleep quality (300-mg group; P ⬍0.05 all parameters vs placebo). The most commonly reported adverse events for both studies were constipation, dizziness, nausea, headache, and somnolence. Based on the WOMAC OA Index scores and pain intensity VAS scores in this combined analysis of 2 studies, tramadol ER showed significant improvement in pain, stiffness, and functionality, and should be considered for the management of moderate-to-severe chronic pain associated with OA in elderly patients.
(745) Effects of extended-release tramadol on pain-related sleep parameters in osteoarthritis
(747) Open label pilot trial of IV ibandronate for complex regional pain syndrome
J Xiang, C Janagap, D Jordan, G Vorsanger; Ortho-McNeil Janssen Scientific Affairs, Raritan, NJ Given once daily, extended-release (ER) tramadol HCl (ULTRAM® ER) reduces pain and related symptoms of osteoarthritis (OA). Two 12-week, double-blind, placebo-controlled, randomized, parallel-group studies were conducted to compare the analgesic efficacy, safety, and tolerability of tramadol ER (100, 200, 300, and 400 mg for Study A and 100, 200, and 300 mg for Study B) as compared to placebo in patients (20-80 years) with moderate-to-severe pain due to radiographically-confirmed OA of the knee or hip (Study A, N ⫽ 1020; Study B, N ⫽ 1011). The effects of pain on sleep were evaluated using the Chronic Pain Sleep Inventory (CPSI) based on a 100-mm VAS (0 ⫽ never, 100 ⫽ always) for both studies. The overall quality of sleep was assessed using a 100-mm VAS (0 ⫽ very poor, 100 ⫽ excellent). The present post-hoc analysis evaluated tramadol ER 100, 200, and 300 mg in patients (n ⫽ 1608) from both studies using the CPSI scores to evaluate efficacy. Compared to placebo, all tramadol ER dose groups showed significant improvement in scores from baseline as early as Week 1 and were maintained through Week 12 for overall sleep quality (P ⱕ0.022). The tramadol ER 200- and 300-mg groups achieved significant improvement in scores from baseline at Week 1 through Week 12 and tramadol ER 100 mg showed significant improvement from baseline at Week 3 through Week 12 in being awakened by pain in the night and in the morning, and less trouble falling asleep due to pain compared to placebo (all, P ⱕ0.046). The most commonly reported adverse events in both studies were dizziness, nausea, constipation, somnolence, and pruritus. Therefore, as shown in these studies, improvements in analgesia were associated with a significant reduction in pain-related sleep problems in patients with OA.
B Breuer, M Pappagallo, R Goldfarb, F Ongseng, C Chen, R Portenoy; Beth Israel Medical Center, New York City, NY Complex regional pain syndrome (CRPS) Type I, also known as reflex sympathetic dystrophy (RSD), usually develops after trauma or immobilization, is characterized by focal pain and autonomic dysregulation, and sometimes focal trophic changes such as osteoporosis. The pathophysiology is unknown and there have been few controlled treatment trials. Small trials with alendronate, pamidronate, and clodronate suggest that bisphosphonates may be effective. Their mode of action in this condition is unknown, but might be related to their inhibition of osteoclast activity or anti-inflammatory activity. To further evaluate the role of bisphosphonates, we conducted a pilot trial of ibandronate, a highly potent bisphosphonate. After a 2-week baseline period, 10 patients with CRPS received three 6-mg-infusions during week3, and were followed from weeks 4-7. Aside from transitory flu-like symptoms, the drug was well tolerated. Post-intervention average and worst pain ratings were significantly improved over baseline (P⫽0.0065, 0.0036, respectively); as were several neuropathic pain descriptors: unpleasantness, sensitivity, depth (all Psⱕ0.005); intensity, surface, heat (all Psⱕ0.01); cold, sharpness, dullness (all Psⱕ0.03). Subjects with baseline bone scans showing greater tracer uptake in the affected limb (compared to unaffected limb), improved more than those having decreased uptake in the heat, cold, sensitivity, and unpleasantness neuropathic pain aspects (all Psⱕ0.03). Although univariate analyses indicated subjects with hand RSD improved significantly more than those with leg RSD in average and worst pain, as well as in many neuropathic pain aspects, multivariate analyses indicated greater improvement only in the time aspect of neuropathic time; i.e., they were less likely to have pain ALL OF THE TIME (p⫽0.0010). While range of motion did not improve, post-intervention, the final physical examination showed a 2-point improvement over baseline in hyperalgesia and allodynia (both Ps⬍0.005). These data indicate that a placebo-controlled trial is warranted to definitively determine the analgesic efficacy of ibandronate for CRPS.
S37 (746) Effects of extended-release tramadol on osteoarthritis pain in the elderly J Xiang, M Siccardi, C Janagap, G Vorsanger; Ortho-McNeil Janssen Scientific Affairs, Raritan, NJ Given once daily, extended-release (ER) tramadol HCl (ULTRAM® ER) reduces pain and related symptoms of osteoarthritis (OA). Two 12-week, double-blind, placebo-controlled, randomized, parallel-group studies were conducted to compare the analgesic efficacy, safety, and tolerability of tramadol ER (100, 200, 300, and 400 mg for Study A and 100, 200, and 300 mg for Study B) as compared to placebo in patients (20-80 years) with moderate-to-severe pain due to radiographically-confirmed OA of the knee or hip (Study A, N⫽1020; Study B, N⫽1011). This post-hoc analysis evaluated tramadol ER in patients ⱖ65 years (n⫽556) from both studies. Patients rated their arthritis pain utilizing a 100-mm (0⫽no pain, 100⫽extreme pain) visual analog scale (VAS); pain and related symptoms were assessed using the WOMAC OA index. Sleep effects were evaluated using the Chronic Pain Sleep Inventory scores based on a 100-mm VAS (0⫽never, 100⫽always). From baseline to Week 12, this analysis demonstrated: a significant improvement in the pain, physical function, and joint stiffness subscales of the WOMAC OA index and the composite score, and pain intensity VAS scores in the index and nonindex joints for the tramadol ER 300-mg group (P ⱕ0.035 vs placebo); a significant decrease in awakening by pain at night and trouble falling asleep (100-, 200-, 300-mg groups); a significant decrease in awakening by pain in the morning (200- and 300-mg groups); and significantly better sleep quality (300-mg group; P ⬍0.05 all parameters vs placebo). The most commonly reported adverse events for both studies were constipation, dizziness, nausea, headache, and somnolence. Based on the WOMAC OA Index scores and pain intensity VAS scores in this combined analysis of 2 studies, tramadol ER showed significant improvement in pain, stiffness, and functionality, and should be considered for the management of moderate-to-severe chronic pain associated with OA in elderly patients.
(745) Effects of extended-release tramadol on pain-related sleep parameters in osteoarthritis
(747) Open label pilot trial of IV ibandronate for complex regional pain syndrome
J Xiang, C Janagap, D Jordan, G Vorsanger; Ortho-McNeil Janssen Scientific Affairs, Raritan, NJ Given once daily, extended-release (ER) tramadol HCl (ULTRAM® ER) reduces pain and related symptoms of osteoarthritis (OA). Two 12-week, double-blind, placebo-controlled, randomized, parallel-group studies were conducted to compare the analgesic efficacy, safety, and tolerability of tramadol ER (100, 200, 300, and 400 mg for Study A and 100, 200, and 300 mg for Study B) as compared to placebo in patients (20-80 years) with moderate-to-severe pain due to radiographically-confirmed OA of the knee or hip (Study A, N ⫽ 1020; Study B, N ⫽ 1011). The effects of pain on sleep were evaluated using the Chronic Pain Sleep Inventory (CPSI) based on a 100-mm VAS (0 ⫽ never, 100 ⫽ always) for both studies. The overall quality of sleep was assessed using a 100-mm VAS (0 ⫽ very poor, 100 ⫽ excellent). The present post-hoc analysis evaluated tramadol ER 100, 200, and 300 mg in patients (n ⫽ 1608) from both studies using the CPSI scores to evaluate efficacy. Compared to placebo, all tramadol ER dose groups showed significant improvement in scores from baseline as early as Week 1 and were maintained through Week 12 for overall sleep quality (P ⱕ0.022). The tramadol ER 200- and 300-mg groups achieved significant improvement in scores from baseline at Week 1 through Week 12 and tramadol ER 100 mg showed significant improvement from baseline at Week 3 through Week 12 in being awakened by pain in the night and in the morning, and less trouble falling asleep due to pain compared to placebo (all, P ⱕ0.046). The most commonly reported adverse events in both studies were dizziness, nausea, constipation, somnolence, and pruritus. Therefore, as shown in these studies, improvements in analgesia were associated with a significant reduction in pain-related sleep problems in patients with OA.
B Breuer, M Pappagallo, R Goldfarb, F Ongseng, C Chen, R Portenoy; Beth Israel Medical Center, New York City, NY Complex regional pain syndrome (CRPS) Type I, also known as reflex sympathetic dystrophy (RSD), usually develops after trauma or immobilization, is characterized by focal pain and autonomic dysregulation, and sometimes focal trophic changes such as osteoporosis. The pathophysiology is unknown and there have been few controlled treatment trials. Small trials with alendronate, pamidronate, and clodronate suggest that bisphosphonates may be effective. Their mode of action in this condition is unknown, but might be related to their inhibition of osteoclast activity or anti-inflammatory activity. To further evaluate the role of bisphosphonates, we conducted a pilot trial of ibandronate, a highly potent bisphosphonate. After a 2-week baseline period, 10 patients with CRPS received three 6-mg-infusions during week3, and were followed from weeks 4-7. Aside from transitory flu-like symptoms, the drug was well tolerated. Post-intervention average and worst pain ratings were significantly improved over baseline (P⫽0.0065, 0.0036, respectively); as were several neuropathic pain descriptors: unpleasantness, sensitivity, depth (all Psⱕ0.005); intensity, surface, heat (all Psⱕ0.01); cold, sharpness, dullness (all Psⱕ0.03). Subjects with baseline bone scans showing greater tracer uptake in the affected limb (compared to unaffected limb), improved more than those having decreased uptake in the heat, cold, sensitivity, and unpleasantness neuropathic pain aspects (all Psⱕ0.03). Although univariate analyses indicated subjects with hand RSD improved significantly more than those with leg RSD in average and worst pain, as well as in many neuropathic pain aspects, multivariate analyses indicated greater improvement only in the time aspect of neuropathic time; i.e., they were less likely to have pain ALL OF THE TIME (p⫽0.0010). While range of motion did not improve, post-intervention, the final physical examination showed a 2-point improvement over baseline in hyperalgesia and allodynia (both Ps⬍0.005). These data indicate that a placebo-controlled trial is warranted to definitively determine the analgesic efficacy of ibandronate for CRPS.