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

A Randomized, Multi-center, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen and Placebo in Subjects With Osteoarthritis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00404183

Enrollment

120

Registered

2006-11-28

Start date

2004-08-31

Completion date

Unknown

Last updated

2011-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pain associated with osteoarthritis

Brief summary

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.

Interventions

DRUGExtended-Release Hydrocodone/Acetaminophen

2 tablets BID

DRUGPlacebo

2 tablets BID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being no pain and 100 being worst pain imaginable).	4 weeks	Arthritis Pain Intensity measured by a 100mm Visial Analog Scase (VAS)

Secondary

Measure	Time frame	Description
WOMAC Osteoarthritis Index, SF36	4 weeks	Osteoarthritis Index

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026