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The purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar extraction.
Dosing started within 6 hours after completion of third molar extraction. Study drug was given once every 6 hours for 12 hours (for a total of 2 doses). Participants were randomized to receive placebo or active drug (either experimental drug or comparator). The total dose was the same for both groups receiving active drug, but was given as either 1 dose of extended-release tablets (experimental drug), or 2 doses of immediate-release tablets (active comparator).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-712 | Experimental | 1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). |
|
| Hydrocodone/Acetaminophen | Active Comparator | 2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses). |
|
| Placebo | Placebo Comparator | 2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-712 Extended-release | Drug | ABT-712 extended-release tablet |
|
| 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:
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# 20745 | Austin | Texas | 78705 | United States | ||
| Site Reference ID/Investigator# 20743 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-712 | 1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). |
| FG001 | Hydrocodone/Acetaminophen | 2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses). |
| FG002 | Placebo | 2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ABT-712 | 1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). |
| BG001 | Hydrocodone/Acetaminophen |
| 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 30 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 | ABT-712 | 1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 12.0 | 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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| Hydrocodone/Acetaminophen Immediate-release | Drug | Hydrocodone/acetaminophen immediate-release tablet |
|
| Placebo | Drug | Placebo tablet |
|
| From time of first study drug administration to 12 hours following first study drug administration |
| Time to First Rescue Medication | The median time (minutes) from first dose of study drug to first use of analgesic rescue medication. | From time of first study drug administration to 12 hours following first study drug administration |
| Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details. | AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 30 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days). |
| San Marcos |
| Texas |
| 78666 |
| United States |
| Site Reference ID/Investigator# 20744 | Salt Lake City | Utah | 84117 | United States |
2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
| BG002 | Placebo | 2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Hydrocodone/Acetaminophen | 2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses). |
| OG002 | Placebo | 2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 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 | Time to First Rescue Medication | The median time (minutes) from first dose of study drug to first use of analgesic rescue medication. | 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 |
|
|
|
| Secondary | Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 30 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days). |
|
|
|
| 0 |
| 43 |
| 11 |
| 43 |
| EG001 | Hydrocodone/Acetaminophen | 2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses). | 0 | 39 | 10 | 39 |
| EG002 | Placebo | 2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). | 0 | 40 | 13 | 40 |
| NAUSEA | Gastrointestinal disorders | MedDRA version 12.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA version 12.0 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA version 12.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA version 12.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA version 12.0 | 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 |
|
| Any AE at least "probably not" drug related |
|
| Any "severe" AE |
|
| Any SAE |
|
| Any AE leading to discontinuation of study drug |
|
| Any AE leading to death |
|
| Death |
|