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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo, 1 oral tablet every 12 hours |
|
| Hydrocodone/Acetaminophen Extended Release | Experimental | hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocodone/Acetaminophen Extended Release | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From time of first study drug administration to 12 hours following first study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Quintana Diez, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 51464 | Pasadena | California | 91105 | United States | ||
| Site Reference ID/Investigator# 51602 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydrocodone/Acetaminophen Extended Release | 1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses). |
| FG001 | Placebo | 1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydrocodone/Acetaminophen Extended Release | 1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses). |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | scores on a scale | From time of first study drug administration to 12 hours following first study drug administration |
|
AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 32 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hydrocodone/Acetaminophen Extended Release | 1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006853 | Hydrocodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Placebo |
| Drug |
Placebo tablet |
|
| From time of first study drug administration to 12 hours following first study drug administration |
| 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. | From time of first study drug administration to 12 hours following first study drug administration |
| 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. | From time of first study drug administration to 12 hours following first study drug administration |
| Austin |
| Texas |
| 78705 |
| United States |
| Site Reference ID/Investigator# 51344 | Salt Lake City | Utah | 84117 | United States |
1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
| OG001 | Placebo | 1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses). |
|
|
| 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. | All randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | scores on a scale | From time of first study drug administration to 12 hours following first study drug administration |
|
|
|
| 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. | All randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | scores on a scale | From time of first study drug administration to 12 hours following first study drug administration |
|
|
|
| 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. | All randomized participants who received at least 1 dose of study drug. | Posted | Median | 95% Confidence Interval | minutes | From time of first study drug administration to 12 hours following first study drug administration |
|
|
|
| 0 |
| 51 |
| 28 |
| 51 |
| EG001 | Placebo | 1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses). | 0 | 49 | 14 | 49 |
| VOMITING | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| SOMNOLENCE | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |