Pain
Conditions
Keywords
Pain
Brief summary
The purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery.
Detailed description
This was a Phase III, randomized, double blind, placebo controlled, multicenter, repeat dose study of the safety and efficacy of 2 dose levels of Acurox™ Tablets versus placebo for the treatment of moderate to severe postoperative pain following bunionectomy surgery. Patients underwent a primary unilateral first metatarsal bunionectomy with or without ipsilateral hammer toe repair during standardized local anesthesia with intravenous (IV) sedation. Eligible patients who reported moderate or severe pain within 6 hours after surgery entered the Treatment Phase and were randomized to 1 of 3 double blind treatments: placebo tablets or 1 of 2 dose levels of Acurox™ Tablets (ocyxcodone HCl/niacin). The Treatment Phase continued with study medication every 6 hours (irrespective of rescue medication use) for 48 hours (8 doses of study medication). Toradol (ketorolac tromethamine) was available as a rescue medication upon request.
Interventions
DRUGPlacebo
2 tablets every 6 hours for 48 hours
DRUGAcurox 5/30 mg
2 tablets every 6 hours for 48 hours
DRUGAcurox 7.5/30
2 tablets every 6 hours for 48 hours
Sponsors
Acura Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is male or female at least 18 years of age * For women of child-bearing potential: woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control * Patient is scheduled to have a bunionectomy * Patient must be willing to stay at the study site for at least 48 hours from the initial dose of study medication post-surgery
Exclusion criteria
* Patient has a current disease or history of a disease that will impact the study or the patient's well-being * Patient has used or intends to use any of the medications that are prohibited by the protocol * Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen * Patient is hypersensitive to any of the medications to be used in the study * Patient has taken another investigational drug within 30 days prior to Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SPID48 | 48 hours | Time weighted Sum of Pain Intensity Differences over the first 48 hours (SPID48) is the sum of the Pain Intensity Difference (PID) scores observed at 0.5 , 1, 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours post-dose. Pain Intensity scores at each timepoint are based on a 100 mm visual analog scale (VAS) from 0 = no pain to 100 = worst pain imaginable. PID is calculated as the timepoint score less the baseline pre-dose score (i.e. PID.5 = PI.5 - PI0). SPID48 = the PID for each timepoint multiplied by a time weighting factor; which is the difference (in hours) between the PID observation and prior observation. SPID48 = PID.5\*.5 + PID1\*.5 + PID2\*1 + PID3\*1 + PID4\*1 + PID6\*2 +PID12\*6 + PID18\*6 +PID24\*6 + PID30\*6 + PID36\*6 + PID42\*6 + PID48\*6. The maximum SPID48 value is 4,800 (assumes PI0 of 100 and a PI of 0 at all subsequent timepoints) with a midpoint SPID48 of 2,400 (PI0=50 and PI of 0 at all subsequent readings). |
Participant flow
Recruitment details
405 post-bunionectomy patients
Pre-assignment details
Subjects dose immediately post-surgery when pain intensity was equal to or greater than moderate. Dosed and followed for 48 hours.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 2x Placebo Tablets | 136 |
| Acurox 5/30 2x oxycodone/niacin 5/30mg tablets | 135 |
| Acurox 7.5/30 2x oxycodone/niacin 7.5/30mg tablets | 134 |
| Total | 405 |
Baseline characteristics
| Characteristic | Acurox 5/30 | Acurox 7.5/30 | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 18 Participants | 19 Participants | 55 Participants |
| Age, Categorical Between 18 and 65 years | 117 Participants | 116 Participants | 117 Participants | 350 Participants |
| Age, Continuous | 41.8 years | 41.6 years | 42.0 years | 41.8 years |
| Region of Enrollment United States | 135 participants | 134 participants | 136 participants | 405 participants |
| Sex: Female, Male Female | 125 Participants | 120 Participants | 114 Participants | 359 Participants |
| Sex: Female, Male Male | 10 Participants | 14 Participants | 22 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 136 | 0 / 135 | 0 / 134 |
| other Total, other adverse events | 51 / 136 | 104 / 135 | 117 / 134 |
| serious Total, serious adverse events | 0 / 136 | 0 / 135 | 0 / 134 |
Outcome results
Primary
SPID48
Time weighted Sum of Pain Intensity Differences over the first 48 hours (SPID48) is the sum of the Pain Intensity Difference (PID) scores observed at 0.5 , 1, 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours post-dose. Pain Intensity scores at each timepoint are based on a 100 mm visual analog scale (VAS) from 0 = no pain to 100 = worst pain imaginable. PID is calculated as the timepoint score less the baseline pre-dose score (i.e. PID.5 = PI.5 - PI0). SPID48 = the PID for each timepoint multiplied by a time weighting factor; which is the difference (in hours) between the PID observation and prior observation. SPID48 = PID.5\*.5 + PID1\*.5 + PID2\*1 + PID3\*1 + PID4\*1 + PID6\*2 +PID12\*6 + PID18\*6 +PID24\*6 + PID30\*6 + PID36\*6 + PID42\*6 + PID48\*6. The maximum SPID48 value is 4,800 (assumes PI0 of 100 and a PI of 0 at all subsequent timepoints) with a midpoint SPID48 of 2,400 (PI0=50 and PI of 0 at all subsequent readings).
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | SPID48 | 604.48 score on a scale | Standard Deviation 1124.857 |
| Acurox 5/30 | SPID48 | 998.46 score on a scale | Standard Deviation 1102.164 |
| Acurox 7.5/30 | SPID48 | 1224.97 score on a scale | Standard Deviation 1128.569 |