Phase 2
Completed N=129
Intravenous Tapentadol in Post-Bunionectomy Pain
Bunion · Postoperative Pain
Source: ClinicalTrials.gov NCT01435577 ↗
Enrolled (actual)
129
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcomePrimary: Sum of Pain Intensity Differences (SPID 24) — -51.23; 25.46 units on a scale
Summary
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Intensity Differences (SPID 24) |
-51.23; 25.46 | — |
| SECONDARY Mean Pain Intensity Scores at Fixed Time Points |
7.2; 7.3; 3.7; 7.1; 3.1; 7.4 | — |
| SECONDARY Pain Intensity Differences at Fixed Time Points |
-3.5; -0.2; -4.1; 0.1; -3.5; 0.5 | — |
| SECONDARY Patient Global Impression of Change After 12 Hours of Treatment |
11; 0; 20; 1; 14; 9 | — |
| SECONDARY Patients Global Impression of Change After 24 Hours of Treatment |
13; 0; 26; 5; 11; 6 | — |
| SECONDARY Patient Global Impression of Change After 48 Hours of Treatment |
19; 2; 24; 8; 4; 2 | — |
| SECONDARY Sum of Pain Intensity Differences After 60 Minutes |
-3.65; 0.26 | — |
| SECONDARY Sum of Pain Intensity Differences After 4 Hours |
-6.76; 4.22 | — |
| SECONDARY Sum of Pain Intensity Differences After 8 Hours |
-9.9; 9.74 | — |
| SECONDARY Sum of Pain Intensity Differences After 12 Hours |
-14.98; 14.82 | — |
| SECONDARY Sum of Pain Intensity Differences After 48 Hours |
-122.93; 45.86 | — |
| SECONDARY Number of Participants With 30% Response After 12 Hours, Based on Pain Intensity Scores |
27; 1 | — |
| SECONDARY Number of Participants With 30% Response After 24 Hours, Based on Pain Intensity Scores |
31; 4 | — |
| SECONDARY Number of Participants With 30% Response After 48 Hours, Based on Pain Intensity Scores |
8; 1 | — |
| SECONDARY Number of Participants With 50% Response After 12 Hours, Based on Pain Intensity Scores |
18; 1 | — |
| SECONDARY Number of Participants With 50% Response After 24 Hours, Based on Pain Intensity Scores |
24; 1 | — |
| SECONDARY Number of Participants With 50% Response After 48 Hours, Based on Pain Intensity Scores |
6; 0 | — |
| SECONDARY Time to First Rescue Medication |
5.4; 2.1 | — |
| SECONDARY Time to Perceptible Pain Relief |
0.2 | — |
| SECONDARY Time to Meaningful Pain Relief |
0.3 | — |
| SECONDARY Pharmacokinetic Concentrations of Tapentadol |
201.2; 99.5; 76.4; 38.2; 73.2; 70.3 | — |
| SECONDARY Pharmacokinetic Concentrations of Tapentadol-O-glucuronide |
26.4; 290.4; 488.2; 452.4; 1048.7; 945.1 | — |
| SECONDARY Mean Pain Intensity Scores at Relative Time- Tapentadol Randomized Participants |
7.2; 3.6; 7.3; 4.7; 7.2; 6.1 | — |
| SECONDARY Mean Pain Intensity Scores at Relative Time - Matching Placebo Randomized Participants |
7.3; 7.8; 8.4; 8.6; 7.9; 7.9 | — |
Eligibility Criteria
Inclusion Criteria
- Scheduled to undergo primary unilateral first metatarsal bunionectomy
- Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active
- Qualifying pain intensity (within a maximum of 5 hours after the last surgical stitch) and Baseline pain intensity (last pain score measured within 10 minutes before dosing) 5 on an 11-point (0 to 10) pain intensity numerical rating scale (NRS).
Exclusion Criteria
- History of malignancy within the past 2 years
- Current or history of alcohol or drug abuse.
- Clinically relevant pulmonary, gastrointestinal, endocrine, metabolic, neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately
- History of seizure disorder, epilepsy, or any condition that would put the subject at risk of seizures
- Severely impaired renal function
- Moderately or severely impaired hepatic function
- Contraindications, or a history of allergy or hypersensitivity, to tapentadol, ibuprofen, or excipients
- Use of prohibited concomitant medication, or not allowed use of restricted concomitant medication
Data sourced from ClinicalTrials.gov (NCT01435577). 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.