Low Back Pain Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) for the Treatment of Acute Low Back Pain
The purpose of this study is to explore the pain-relieving effects and safety of Tramadol HCl/acetaminophen as compared to placebo in patients experiencing acute low back pain. Tramadol HCl/acetaminophen is approved for short-term management of acute pain. The combination of tramadol HCl/acetaminophen has been shown to be effective for the treatment of acute musculoskeletal pain. Patients who experienced at least moderate acute low back pain for 2 to 10 days before study entry will be randomized to receive either tramadol HCl/acetaminophen or placebo.
Tramadol HCl/acetaminophen is approved for short-term (five days or less) management of
acute pain. The combination of tramadol HCl/acetaminophen has been shown to be effective for
the treatment of acute musculoskeletal pain. The current study is a multicenter, randomized,
double-blind, placebo-controlled, parallel group study. Patients with acute low back pain
for 2 to 10 days before study entry will be enrolled. At the screening visit, patients will
complete questionnaires about their level of pain and disability. Patients will be
randomized (like the toss of a coin) to receive either tramadol HCl/acetaminophen or
placebo. Patients will take 2 tablets of study medication every 4 to 6 hours as needed for
low back pain, but not more than 8 tablets per 24-hour period. Patients will call the
Interactive Voice Response (IVR) system to complete a pain assessment prior to taking the
first dose of study medication. Also starting on Day 1, patients will call the IVR system
every night at bedtime for the remainder of the study, to complete assessments related to
the following: low back pain and pain relief in the last 24 hours, current pain, pain
interference with sleep and the number of study medication tablets and doses taken that day.
The objective of this study is to compare the effectiveness and safety of tramadol
HCl/acetaminophen versus placebo for the treatment of acute low back pain.
2 tramadol/acetaminophen 37.5/325 milligram oral tablets or 2 placebo tablets every 4 to 6
hours as needed for low back pain, but no more than 8 tablets per day, for 5 days, or until
there is no further need for pain medication
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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