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

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00404183

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Extended-Release Hydrocodone/Acetaminophen Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Acetaminophen CT 2584 Hydrocodone Hydrocodone bitartrate Hycodan

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Arthritis Pain Intensity measured by a 100mm Visial Analog Scase (VAS)

Secondary Outcome Measures:

WOMAC Osteoarthritis Index, SF36 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Osteoarthritis Index

Enrollment:	120
Study Start Date:	August 2004
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: hydrocodone/acetaminophen extended release	Drug: Extended-Release Hydrocodone/Acetaminophen 2 tablets BID Other Names: ABT-712 hydrocodone/acetaminophen extended release
Placebo Comparator: Placebo	Drug: Placebo 2 tablets BID Other Name: placebo

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404183

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Rita Jain, MD

Abbott

More Information

No publications provided

Responsible Party:	Victor Jorden, MD, Abbott
ClinicalTrials.gov Identifier:	NCT00404183 History of Changes
Other Study ID Numbers:	M03-643
Study First Received:	November 26, 2006
Last Updated:	January 14, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Pain associated with osteoarthritis

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Acetaminophen, hydrocodone drug combination
Analgesics
Hydrocodone
Oxycodone
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions

Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012