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

NCT00404183 | Completed Phase 2

• 1 other identifier: M03-643
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Keywords

Pain associated with osteoarthritis

Outcome Measures

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").

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

  4 weeks

Secondary Outcomes (1)

• WOMAC Osteoarthritis Index, SF36

  4 weeks

Study Arms (2)

hydrocodone/acetaminophen extended release

EXPERIMENTAL

Drug: Extended-Release Hydrocodone/Acetaminophen

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Extended-Release Hydrocodone/Acetaminophen DRUG

2 tablets BID

Also known as: ABT-712, hydrocodone/acetaminophen extended release

hydrocodone/acetaminophen extended release

Placebo DRUG

2 tablets BID

Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen; Hydrocodone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Rita Jain, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 26, 2006
• First Posted: November 28, 2006
• Study Start: August 1, 2004
• Primary Completion: March 1, 2005
• Last Updated: January 19, 2011

Record last verified: 2011-01