A Study of Pain Relief in Osteoarthritis - Full Text View

Purpose

The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR to placebo in subjects with osteoarthritis (OA) of the hip or knee.

Condition	Intervention	Phase
Osteoarthritis	Drug: hydrocodone / acetaminophen extended release Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase 3, Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy of Extended Release Hydrocodone/Acetaminophen Tablets (Vicodin CR) to Placebo in Subjects With Osteoarthritis

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Acetaminophen Hydrocodone Hydrocodone bitartrate Hycodan

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Pain Intensity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS)

Secondary Outcome Measures:

Pain intensity difference (PID) from baseline to each scheduled evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
SF-36v2 Health Status Survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]


Enrollment:	873
Study Start Date:	February 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: hydrocodone/acetaminophen extended release	Drug: hydrocodone / acetaminophen extended release 2 tablets twice daily Other Name: ABT-712
Placebo Comparator: Placebo	Drug: Placebo 2 tablets twice daily Other Name: Placebo

Eligibility


Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females ages 21 to 80
If female, must be of non-child bearing potential or practicing birth control
Has osteoarthritis of the hip or knee
Requires therapeutic doses of medication for osteoarthritis pain
Has sufficient pain to justify the use of around-the-clock opioids

Exclusion Criteria:

Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study
Is allergic to or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
Cannot discontinue pain medications, even for the short time prior to the study start
Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery
Has a history of gastric bypass surgery or preexisting severe gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract
Has a history of malnutrition or starvation
Has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day
Has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder
Pregnant or breastfeeding females
Is incapacitated, bedridden or confined to a wheelchair
Has initiated any new therapy or medication for OA within 1 month of screening
Has had surgery, certain types of procedures, or received certain medications for osteoarthritis within a specified time frame
Has other conditions that may cause pain, such as rheumatoid arthritis or gout

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298974

Show 83 Study Locations

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Rita Jain, M.D.	Abbott

More Information

No publications provided


Responsible Party:	Earle Lockhart,MD, Abbott
ClinicalTrials.gov Identifier:	NCT00298974 History of Changes
Other Study ID Numbers:	M04-697
Study First Received:	March 2, 2006
Last Updated:	January 24, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:


Osteoarthritis of the hip or knee

Additional relevant MeSH terms:


Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Acetaminophen Acetaminophen, hydrocodone drug combination Hydrocodone Oxycodone Analgesics Analgesics, Non-Narcotic Analgesics, Opioid Anti-Inflammatory Agents	Anti-Inflammatory Agents, Non-Steroidal Antipyretics Antirheumatic Agents Antitussive Agents Central Nervous System Agents Central Nervous System Depressants Narcotics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015