A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery

Condition(s) targeted: Pain

Intervention: Hydrocodone/Acetaminophen (Vicodin® CR) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Rita Jain, MD, Study Director, Affiliation: Abbott

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.

Official title: A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time-interval-weighted sum of pain relief (TOTPAR) score for 0 to 12 hours following the first dose of study drug administration.

Secondary outcome:

Time-interval-weighted sum of pain intensity difference (SPID) scores

Time interval weighted sum of pain relief and pain intensity difference (SPRID)

Time to first noticeable pain relief (i.e., onset of pain)

Time to first meaningful pain relief (i.e, 50% reduction in pain from baseline)

Time to rescue medication

Proportion of subjects experiencing meaningful pain relief after dosing

Mean pain relief and pain intensity at each scheduled pain evaluation

Subject Global Evaluation

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female ages 18 to 65

- Females must be of non-childbearing potential or practicing birth control

- Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy

surgery

Exclusion Criteria:

- Is allergic to or has a serious reaction to hydrocodone, or other opioids,

acetaminophen, lidocaine or propofol, and/or similar drugs

- Has initiated corticosteroid therapy within the past month or is scheduled to receive

any corticosteroid during the study

- Is associated with any currently ongoing research study

Starting date: October 2003
Ending date: March 2004
Last updated: July 23, 2007