Status:
COMPLETED
A Study of Pain Relief in Low Back Pain
Lead Sponsor:
Abbott
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
21-75 years
Phase:
PHASE3
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
770 Patients enrolled
Trial Details
Trial ID
NCT00325949
Start Date
May 1 2006
End Date
June 1 2007
Last Update
July 25 2011
Active Locations (63)
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1
Site Ref # / Investigator 2216
Hueytown, Alabama, United States, 35023
2
Site Ref # / Investigator 2605
Phoenix, Arizona, United States, 85023
3
Site Ref # / Investigator 1990
Phoenix, Arizona, United States, 85029
4
Site Ref # / Investigator 1974
Tempe, Arizona, United States, 85282