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Completed

NCT Number: NCT00404183

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extended-Release Hydrocodone/Acetaminophen

Drug

2 tablets BID

Other names: ABT-712, hydrocodone/acetaminophen extended release

Placebo

Drug

2 tablets BID

Primary outcomes

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

    Time frame: 4 weeks

    Arthritis Pain Intensity measured by a 100mm Visial Analog Scase (VAS)

Secondary outcomes

  1. WOMAC Osteoarthritis Index, SF36

    Time frame: 4 weeks

    Osteoarthritis Index

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
First posted
Nov 28, 2006
Registry last updated
Jan 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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