A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis

Condition(s) targeted: Pain

Intervention: Extended-Release 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 Extended Release Hydrocodone/Acetaminophen with placebo over a 5-week dosing period in patients with osteoarthritis.

Official title: A Randomized, Multi-Center, Double-Blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis

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

Primary outcome: Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable").

Secondary outcome:

WOMAC Osteoarthritis Index

MOS Sleep Scale

Pain Intensity difference as assessed by the Subject’s Assessment of Arthritis Pain Intensity by VAS (at each scheduled assessment other than final)

Subject’s Global Assessment of Study Drug

Subject’s and Physician’s Global Assessment of Arthritis Status

Time-interval weighted measure of pain intensity difference from baseline (area under the curve) divided by the maximum benefit possible for an individual subject

Treatment responders

SF-36v2TM Health Status Survey (Acute)

Minimum age: 21 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males or females ages 21 to 75

- Has osteoarthritis of the hip or knee

- Requires therapeutic doses of medications for osteoarthritis

- If female, must be of non-childbearing potential or practicing birth control

- Has sufficient pain to justify the use of round-the-clock opioids

Exclusion Criteria:

- Has received certain types of procedures or received certain medications for

osteoarthritis within a specific timeframe

- Has certain medical conditions which may interfere with pain assessments

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

acetaminophen

- Has had certain infections, injuries or illnesses within the last month

- Has had major abdominal surgery, certain diseases that may cause intestinal narrowing,

or has a history of constipation, diarrhea or nausea and vomiting

- Is receiving chemotherapy, or has been diagnosed with certain cancers within the past

5 years

- Has a history of major psychiatric disorders or requires treatment with certain drugs

for depression

- Cannot discontinue pain medications, even for a short time, prior to the study start

Starting date: August 2004
Ending date: March 2005
Last updated: July 23, 2007