| May 11, 2006 |
| October 24, 2007 |
| May 2006 |
| |
| Pain Intensity Difference from randomization baseline to each subject's final assessment |
| Same as current |
| Complete list of historical versions of study NCT00325949 on ClinicalTrials.gov Archive Site |
- Time to withdrawal due to lack of efficacy during the Double-blind Maintenance Period
- Pain Intensity Difference from randomization baseline to each scheduled assessment
- Global Assessments of Study Drug and Back Pain Status
- Roland-Morris Disability Questionnaire
|
| Same as current |
| |
| A Study of Pain Relief in Low Back Pain |
| A Phase 3, Open-Label Period Followed By a Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) Compared to Placebo in Subjects With Chronic Low Back Pain |
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 III |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Chronic Low Back Pain |
| Drug: Extended release hydrocodone and acetaminophen (Vicodin CR) |
| |
| |
| |
| Completed |
| 450 |
|
|
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
|
| Both |
| 21 Years to 75 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00325949 |
|
| M05-790 |
| Abbott |
|
| Study Director: |
Earle Lockhart, M.D. |
Abbott |
|
|
| Abbott |
| October 2007 |
