Pain
Conditions
Brief summary
The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate to severe pain following bunionectomy.
Detailed description
The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol. After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 2 treatment arms: hydrocodone/acetaminophen extended release or placebo.
Interventions
DRUGPlacebo
Placebo tablet
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy
Exclusion criteria
* Subjects who underwent Base wedge osteotomy and / or Long-Z Hart bunionectomy procedures * Drug allergies to hydrocodone, acetaminophen * Clinically significant or uncontrolled medical disorders or illness - history of drug or alcohol abuse / addiction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS) | From time of first study drug administration to 12 hours following first study drug administration | Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TOTPAR (Total Pain Relief) | From time of first study drug administration to 12 hours following first study drug administration | TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule. |
| SPRID (Pain Relief and Pain Intensity Difference) | From time of first study drug administration to 12 hours following first study drug administration | SPRID was defined as the sum of Pain Relief score (TOTPAR, See Outcome Measure 2 for details\*) plus the Pain Intensity Difference (SPID) Categorical score, where participants assessed pain intensity on a Categorical Pain Intensity Scale by answering the following question: My pain at this time is… with one of the following responses: no pain or none, mild pain, moderate pain, or severe pain). Higher mean SPRID scores indicated better pain control. The SPRID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule. |
| Time to Perceptible and Meaningful Pain Relief | From time of first study drug administration to 12 hours following first study drug administration | The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hydrocodone/Acetaminophen Extended Release 1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses). | 51 |
| Placebo 1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses). | 49 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Hydrocodone/Acetaminophen Extended Release | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 39.0 years STANDARD_DEVIATION 11.79 | 41.6 years STANDARD_DEVIATION 13.85 | 40.3 years STANDARD_DEVIATION 12.84 |
| Sex: Female, Male Female | 41 Participants | 44 Participants | 85 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 51 | 14 / 49 |
| serious Total, serious adverse events | 0 / 51 | 0 / 49 |
Outcome results
Primary
Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
Time frame: From time of first study drug administration to 12 hours following first study drug administration
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Hydrocodone/Acetaminophen Extended Release | Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS) | 259.0 scores on a scale | Standard Error 37.52 |
| Placebo | Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS) | 39.4 scores on a scale | Standard Error 38.1 |
Secondary
SPRID (Pain Relief and Pain Intensity Difference)
SPRID was defined as the sum of Pain Relief score (TOTPAR, See Outcome Measure 2 for details\*) plus the Pain Intensity Difference (SPID) Categorical score, where participants assessed pain intensity on a Categorical Pain Intensity Scale by answering the following question: My pain at this time is… with one of the following responses: no pain or none, mild pain, moderate pain, or severe pain). Higher mean SPRID scores indicated better pain control. The SPRID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
Time frame: From time of first study drug administration to 12 hours following first study drug administration
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Hydrocodone/Acetaminophen Extended Release | SPRID (Pain Relief and Pain Intensity Difference) | 23.4 scores on a scale | Standard Error 2.75 |
| Placebo | SPRID (Pain Relief and Pain Intensity Difference) | 7.2 scores on a scale | Standard Error 2.78 |
Secondary
Time to Perceptible and Meaningful Pain Relief
The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.
Time frame: From time of first study drug administration to 12 hours following first study drug administration
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hydrocodone/Acetaminophen Extended Release | Time to Perceptible and Meaningful Pain Relief | Time to Onset of Perceptible Pain Relief | 34.0 minutes |
| Hydrocodone/Acetaminophen Extended Release | Time to Perceptible and Meaningful Pain Relief | Time to Onset of Meaningful Pain Relief | 119.0 minutes |
| Placebo | Time to Perceptible and Meaningful Pain Relief | Time to Onset of Perceptible Pain Relief | 56.0 minutes |
| Placebo | Time to Perceptible and Meaningful Pain Relief | Time to Onset of Meaningful Pain Relief | NA minutes |
Secondary
TOTPAR (Total Pain Relief)
TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
Time frame: From time of first study drug administration to 12 hours following first study drug administration
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Hydrocodone/Acetaminophen Extended Release | TOTPAR (Total Pain Relief) | 15.4 scores on a scale | Standard Error 1.72 |
| Placebo | TOTPAR (Total Pain Relief) | 5.3 scores on a scale | Standard Error 1.74 |