Phase 3
Completed N=60
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo
Source: ClinicalTrials.gov NCT01813890 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Sum of Pain Intensity Difference (SPID) Over 48 Hours — 50.8; 168.4; 194.9 units on a scale — p=0.006
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Intensity Difference (SPID) Over 48 Hours |
50.8; 168.4; 194.9 | 0.006 sig |
| SECONDARY Time to First Rescue Medication Use |
NA; NA; NA | — |
| SECONDARY Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours |
35.0; 66.7; 73.7; 40.0; 66.7; 73.7 | — |
| SECONDARY Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours |
20.0; 42.9; 57.9; 35.0; 61.9; 73.7 | — |
| SECONDARY Sum of Pain Intensity Differences (SPID) Over 12, 24 and 72 Hours |
7.6; 30.3; 34.7; 16.7; 67.5; 82.0 | — |
| SECONDARY Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours |
13.0; 22.5; 24.4; 28.0; 48.2; 54.1 | — |
| SECONDARY Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours |
20.7; 52.8; 59.1; 44.7; 115.7; 136.0 | — |
| SECONDARY Patient Global Impression of Change (PGI-C) Score at 72 Hours |
40.0; 71.4; 73.7; 10.0; 14.3; 5.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must be undergoing primary unilateral first metatarsal bunionectomy that includes a distal Chevron osteotomy only, with or without the Akin procedure
- Patients must be healthy or medically stable on the basis of clinical laboratory tests performed at screening
- Women must be postmenopausal, surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control and have a negative serum pregnancy test at screening and a negative urine pregnancy test before surgery
- If a male, must use an approved method of birth control and does not donate sperm from the day of study drug administration until 3 months afterwards
- Qualifying baseline Pain Intensity must be rated as greater than or equal to 4 on an 11-point (0 to 10) PI NRS, recorded within 30 minutes before randomization, no earlier than 10 hours after the first surgical incision and within 9 hours after termination of the continuous Popliteal Sciatic Block (PSB) infusion Exclusion Criteria: - History of seizure disorder or epilepsy, severe traumatic brain injury, episode(s) of unconsciousness of more than 24 hours duration, malignancy in the past 2 years with the exception of successfully treated basal cell carcinoma
- Mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening
- Renal insufficiency, impaired hepatic function
- Use of anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, serotonin norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs) or triptans
Data sourced from ClinicalTrials.gov (NCT01813890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.