Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210561
Status:
TERMINATED
Last Update Posted:
2011-06-10
First Post:
2005-09-13
Brief Title:
A Study of the Effectiveness and Safety of Tramadol HClAcetaminophen Compared to Placebo in Treating Acute Low Back Pain
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel Group Study to Evaluate the Efficacy and Safety of ULTRACET Tramadol HClAcetaminophen for the Treatment of Acute Low Back Pain
Status:
TERMINATED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was stopped shortly after initiation due to change in strategic direction of the company no safety concerns were observed that impacted this decision
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to explore the pain-relieving effects and safety of Tramadol HClacetaminophen as compared to placebo in patients experiencing acute low back pain Tramadol HClacetaminophen is approved for short-term management of acute pain The combination of tramadol HClacetaminophen 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 HClacetaminophen or placebo
Detailed Description:
Tramadol HClacetaminophen is approved for short-term five days or less management of acute pain The combination of tramadol HClacetaminophen 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 HClacetaminophen 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 HClacetaminophen versus placebo for the treatment of acute low back pain
2 tramadolacetaminophen 375325 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
2 tramadolacetaminophen 375325 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None