Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

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 48 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 48 hours following first study drug administration

Population: All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).

Potentially clinically significant criteria: alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≥3 times upper limit of normal (ULN); calcium ≤1.8 mmol/L.

Time frame: At specified intervals from Screening through 7 days after first dose of study drug

Population: All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).

Potentially clinically significant criteria: Systolic blood pressure (BP) ≤90 mm Hg and ≥20 mm Hg decrease (low) or ≥180 mm Hg and ≥20 mm Hg increase (high); Diastolic BP ≤50 mm Hg and ≥15 mm Hg decrease (low) or ≥105 mm Hg and ≥15 mm Hg increase (high). Heart rate ≤50 beats per minute (bpm) and ≥15 bpm decrease (low) or ≥120 bpm and ≥15 bpm increase (high). Respiratory rate \<10 respirations per minute (rpm) (low) or \>24 rpm (high).

Time frame: At specified intervals from Screening through 7 days after first dose of study drug

Population: All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).

The participant's overall impression of the study drug was obtained on a 5-point categorical scale: excellent; very good; good; fair; poor.

Time frame: From time of first study drug administration to 48 hours following first study drug administration

Population: All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).

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.

Time frame: 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).

Population: All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).

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. Analyses were performed based on the treatment participants actually received (as-treated).

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 48 hours following first study drug administration

Population: All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).