Phase 3
Completed N=901
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
Arthralgia · Bunion · Hallux Valgus · Postoperative Pain
Source: ClinicalTrials.gov NCT00613938 ↗
Enrolled (actual)
901
Serious AEs
0.1%
Results posted
Apr 2010
Primary outcomePrimary: Sum of Pain Intensity Difference Over 48 Hours (SPID48) — 54.1; 122.2; 143.7; 140.3 Scores on a scale — p=<0.001
Summary
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have had a bunionectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Intensity Difference Over 48 Hours (SPID48) |
54.1; 122.2; 143.7; 140.3 | <0.001 sig |
| SECONDARY Time to First Rescue Pain Medication Use. |
— | — |
| SECONDARY The SPID at 12 Hours Relative to First Dose. |
7.5; 21.1; 26.0; 24.9 | — |
| SECONDARY SPID at 24 Hours Relative to First Dose |
12.1; 45.4; 58.1; 53.8 | — |
| SECONDARY Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change to Day 3 |
65.2; 83.2; 87.8; 86.0 | — |
| SECONDARY Total Pain Relief (TOTPAR)at 48 Hours |
68.2; 96.6; 107.5; 105.2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must undergo primary unilateral first metatarsal bunionectomy
- Pain intensity must be moderate to severe following removal of a continuous popliteal sciatic block
- Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active.
Exclusion Criteria
- Patients will be excluded from the study if they have a history of seizure disorder or epilepsy
- History of malignancy within the past 2 years before starting the study
- History of alcohol or drug abuse
- Evidence of active infections that may spread to other areas of the body
- Clinical laboratory values reflecting severe renal insufficiency
- Moderately or severely impaired hepatic function
- Currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI).
Data sourced from ClinicalTrials.gov (NCT00613938). 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.