True Functional Restoration and Analgesia in Non-Radicular Low Back Pain (Covidien)
You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been studied in more than 2,000 pain patients in clinical trials, including individuals with low back pain. About 36 subjects will take part in this study.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||True Functional Restoration and Analgesia in Non-Radicular Low Back Pain: a Prospective Double Blind, Placebo-controlled Study of Hydromorphone ER|
- The efficacy of Exalgo (hydromorphone HCl extended release) in Chronic Non-Radicular Low Back Pain (CNRBP) model syndrome to improve pain, function and activity [ Time Frame: Three visits over eight week period ] [ Designated as safety issue: No ]Intent to treat analyses will compare data from the groups for all participants with at least two data points. A series of mixed design ANOVAs will be completed with data from objective functional testing, quasi-objective functional and psychophysical testing, subject pain questionnaires and subjective perceived function and quality of life.
- The relationship between pain ratings and functioning [ Time Frame: Three visits over an eight week period ] [ Designated as safety issue: No ]A second set of follow-up analyses will test for nonlinear patterns of change over time. It is expected that some outcome factors will show quadratic trends such that, for instance, activity level will change depending on pain ratings.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Sugar pill
Subjects may receive a pill with no medicine.
Drug: Hydromorphone ER
Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
Other Name: Exalgo(hydromorphone HCl), CII (77605306)
No Intervention: Hydromorphone ER
As a participant in this study, you will be asked to come to the Rehabilitation Institute of Chicago (RIC), Center for Pain Studies (446 E Ontario St. Suite 1011, Chicago, IL 60611). Your part in this study will last for 8 weeks and will involve 3 visits to the Rehabilitation Institute of Chicago and anywhere from weekly phone calls to phone calls every other day.
If you are in this study, you will be placed in one of two study groups: one group will receive the study drug and one will receive a placebo. You will be assigned a study group by chance using a process similar to the flip of a coin. This process is called randomization. Neither you nor the study staff will select the group you will be in. A placebo looks like the study drug but is an inactive substance that has no medication. Researchers use a placebo to see if the study drug works better or is safer than not taking anything. You will have a 66% chance of getting the study drug. You will receive placebo at some point during the study but you will not know whether you are receiving placebo or study drug during the entire study. However, if you have a medical emergency, the investigators can get this information.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455519
|United States, Illinois|
|Rehabilitation Institute of Chicago|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Norman Harden, M.D.||Rehabilitation Institute of Chicago|