A Study of Pain Relief in Low Back Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Low Back Pain

In brief

This is a study of the safety and pain-relieving ability of extended release hydrocodone and acetaminophen tablets in patients with moderate to severe low back pain

Key facts

Study ID

NCT00325949

Run by

Abbott

People needed

770

Starts

2006-05-01

Expected to finish

2007-06-01

Last updated by the study team

2011-07-25

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, ages 21-75 years
• If female, must be of non-child bearing potential or practicing birth control
• Has a history of chronic low back pain for at least 6 months
• Requires medication for the management of the chronic low back pain
• Has sufficient pain to justify the use of around-the-clock opioids

You may not qualify if…

• Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study
• Is allergic 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, or plans to have surgery
• Has a history of gastric bypass surgery or preexisting 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
• Is a pregnant or breastfeeding woman
• Is incapacitated, bedridden, or confined to a wheelchair
• Has initiated any new therapy or medication for chronic low back pain within 1 month of screening
• Has had surgery, certain types of low back procedures, injured, or received certain medications for chronic low back pain within a certain specified time frame
• Has back pain due to or associated with certain types of conditions
• Has other conditions that may cause pain, such as rheumatoid arthritis, gout, or fibromyalgia

Where it is running

• Site Ref # / Investigator 2605 — Phoenix, Arizona, United States
• Site Ref # / Investigator 1990 — Phoenix, Arizona, United States
• Site Ref # / Investigator 1974 — Tempe, Arizona, United States
• Site Ref # / Investigator 1977 — Tucson, Arizona, United States
• Site Ref # / Investigator 1992 — Buena Park, California, United States
• Site Ref # / Investigator 1993 — Burbank, California, United States
• Site Ref # / Investigator 2219 — Fair Oaks, California, United States
• Site Ref # / Investigator 1989 — Los Gatos, California, United States
• Site Ref # / Investigator 2157 — Denver, Colorado, United States
• Site Ref # / Investigator 1994 — Trumbull, Connecticut, United States
• Site Ref # / Investigator 2208 — Clearwater, Florida, United States
• Site Ref # / Investigator 2210 — DeLand, Florida, United States
• Site Ref # / Investigator 2207 — Hollywood, Florida, United States
• Site Ref # / Investigator 2204 — Miami, Florida, United States
• Site Ref # / Investigator 2205 — Miami, Florida, United States
• Site Ref # / Investigator 2214 — Oldsmar, Florida, United States
• Site Ref # / Investigator 2135 — Plantation, Florida, United States
• Site Ref # / Investigator 2134 — West Palm Beach, Florida, United States
• Site Ref # / Investigator 1975 — Atlanta, Georgia, United States
• Site Ref # / Investigator 1991 — Decatur, Georgia, United States
• Site Ref # / Investigator 1985 — Chicago, Illinois, United States
• Site Ref # / Investigator 1978 — Evansville, Indiana, United States
• Site Ref # / Investigator 1988 — West Des Moines, Iowa, United States
• Site Ref # / Investigator 2580 — Prairie Village, Kansas, United States
• Site Ref # / Investigator 2216 — Hueytown, Alabama, United States

Full record on ClinicalTrials.gov

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