Trial Outcomes & Findings for Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction (NCT NCT00935311)
NCT ID: NCT00935311
Last Updated: 2014-04-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
From time of first study drug administration to 12 hours following first study drug administration
Results posted on
2014-04-08
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
Placebo
2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
39
|
40
|
|
Overall Study
COMPLETED
|
43
|
39
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
Baseline characteristics by cohort
| Measure |
ABT-712
n=43 Participants
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
n=39 Participants
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
n=40 Participants
2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
22.1 years
STANDARD_DEVIATION 2.83 • n=5 Participants
|
21.4 years
STANDARD_DEVIATION 3.20 • n=7 Participants
|
23.0 years
STANDARD_DEVIATION 4.73 • n=5 Participants
|
22.2 years
STANDARD_DEVIATION 3.70 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From time of first study drug administration to 12 hours following first study drug administrationPopulation: All randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
ABT-712
n=43 Participants
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
n=39 Participants
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
n=40 Participants
2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
|
|---|---|---|---|
|
Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
|
268.8 scores on a scale
Standard Error 44.29
|
230.9 scores on a scale
Standard Error 47.03
|
54.8 scores on a scale
Standard Error 46.19
|
SECONDARY outcome
Timeframe: From time of first study drug administration to 12 hours following first study drug administrationPopulation: All randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
ABT-712
n=43 Participants
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
n=39 Participants
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
n=40 Participants
2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
|
|---|---|---|---|
|
TOTPAR (Total Pain Relief)
|
18.0 scores on a scale
Standard Error 2.06
|
15.9 scores on a scale
Standard Error 2.16
|
10.5 scores on a scale
Standard Error 2.13
|
SECONDARY outcome
Timeframe: From time of first study drug administration to 12 hours following first study drug administrationPopulation: All randomized participants who received at least 1 dose of study drug.
The median time (minutes) from first dose of study drug to first use of analgesic rescue medication.
Outcome measures
| Measure |
ABT-712
n=43 Participants
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
n=39 Participants
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
n=40 Participants
2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
|
|---|---|---|---|
|
Time to First Rescue Medication
|
442.0 minutes
Interval 196.0 to 612.0
|
205.0 minutes
Interval 190.0 to 642.0
|
123.5 minutes
Interval 104.0 to 153.0
|
SECONDARY outcome
Timeframe: 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).Population: All randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
ABT-712
n=43 Participants
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
n=39 Participants
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
n=40 Participants
2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
|
|---|---|---|---|
|
Participants With Adverse Events (AEs)
Any "severe" AE
|
1 participants
|
0 participants
|
2 participants
|
|
Participants With Adverse Events (AEs)
Any SAE
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Adverse Events (AEs)
Death
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Adverse Events (AEs)
Any AE leading to death
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Adverse Events (AEs)
Any AE
|
14 participants
|
12 participants
|
14 participants
|
|
Participants With Adverse Events (AEs)
Any AE at least "possibly" drug related
|
5 participants
|
8 participants
|
4 participants
|
|
Participants With Adverse Events (AEs)
Any AE at least "probably not" drug related
|
9 participants
|
4 participants
|
10 participants
|
|
Participants With Adverse Events (AEs)
Any AE leading to discontinuation of study drug
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
ABT-712
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Hydrocodone/Acetaminophen
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ABT-712
n=43 participants at risk
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
n=39 participants at risk
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
n=40 participants at risk
2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
|
|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/43 • 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).
|
0.00%
0/39 • 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).
|
5.0%
2/40 • 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).
|
|
Gastrointestinal disorders
NAUSEA
|
16.3%
7/43 • 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).
|
17.9%
7/39 • 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).
|
5.0%
2/40 • 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).
|
|
Gastrointestinal disorders
VOMITING
|
2.3%
1/43 • 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).
|
5.1%
2/39 • 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).
|
5.0%
2/40 • 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).
|
|
General disorders
CHILLS
|
0.00%
0/43 • 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).
|
0.00%
0/39 • 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).
|
5.0%
2/40 • 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).
|
|
Nervous system disorders
DIZZINESS
|
2.3%
1/43 • 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).
|
12.8%
5/39 • 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).
|
7.5%
3/40 • 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).
|
|
Nervous system disorders
HEADACHE
|
11.6%
5/43 • 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).
|
0.00%
0/39 • 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).
|
15.0%
6/40 • 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).
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER