A Study of Pain Relief in Low Back Pain

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Oxycodone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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