Trial Outcomes & Findings for Acute Pain Study Following Bunionectomy (NCT NCT01333722)

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

100 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

Participant milestones
Measure	Hydrocodone/Acetaminophen Extended Release 1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).	Placebo 1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
Overall Study STARTED	51	49
Overall Study COMPLETED	51	46
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Hydrocodone/Acetaminophen Extended Release 1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).	Placebo 1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
Overall Study Lack of Efficacy	0	2
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Acute Pain Study Following Bunionectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydrocodone/Acetaminophen Extended Release n=51 Participants 1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).	Placebo n=49 Participants 1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).	Total n=100 Participants Total of all reporting groups
Age, Continuous	39.0 years STANDARD_DEVIATION 11.79 • n=5 Participants	41.6 years STANDARD_DEVIATION 13.85 • n=7 Participants	40.3 years STANDARD_DEVIATION 12.84 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	44 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures
Measure	Hydrocodone/Acetaminophen Extended Release n=51 Participants 1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).	Placebo n=49 Participants 1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)	259.0 scores on a scale Standard Error 37.52	39.4 scores on a scale Standard Error 38.10

SECONDARY outcome

Timeframe: 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.

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

Outcome measures
Measure	Hydrocodone/Acetaminophen Extended Release n=51 Participants 1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).	Placebo n=49 Participants 1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
TOTPAR (Total Pain Relief)	15.4 scores on a scale Standard Error 1.72	5.3 scores on a scale Standard Error 1.74

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Hydrocodone/Acetaminophen Extended Release n=51 Participants 1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).	Placebo n=49 Participants 1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
SPRID (Pain Relief and Pain Intensity Difference)	23.4 scores on a scale Standard Error 2.75	7.2 scores on a scale Standard Error 2.78

SECONDARY outcome

Timeframe: 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.

The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.

Outcome measures

Outcome measures
Measure	Hydrocodone/Acetaminophen Extended Release n=51 Participants 1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).	Placebo n=49 Participants 1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
Time to Perceptible and Meaningful Pain Relief Time to Onset of Perceptible Pain Relief	34.0 minutes Interval 29.0 to 45.0	56.0 minutes Interval 31.0 to 184.0
Time to Perceptible and Meaningful Pain Relief Time to Onset of Meaningful Pain Relief	119.0 minutes Interval 73.0 to 447.0	NA minutes Not available from Kaplan-Meier estimate.

Adverse Events

Hydrocodone/Acetaminophen Extended Release

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hydrocodone/Acetaminophen Extended Release n=51 participants at risk 1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).	Placebo n=49 participants at risk 1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
Gastrointestinal disorders NAUSEA	33.3% 17/51 • 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).	16.3% 8/49 • 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).
Gastrointestinal disorders VOMITING	15.7% 8/51 • 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).	6.1% 3/49 • 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).
Infections and infestations CELLULITIS	7.8% 4/51 • 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).	2.0% 1/49 • 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).
Investigations ALANINE AMINOTRANSFERASE INCREASED	5.9% 3/51 • 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).	0.00% 0/49 • 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).
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	5.9% 3/51 • 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).	0.00% 0/49 • 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).
Nervous system disorders DIZZINESS	13.7% 7/51 • 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).	6.1% 3/49 • 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).
Nervous system disorders HEADACHE	11.8% 6/51 • 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).	14.3% 7/49 • 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).
Nervous system disorders SOMNOLENCE	9.8% 5/51 • 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).	0.00% 0/49 • 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).

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