Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236483
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-10-07
Brief Title:
A Comparison of the Effectiveness and Safety of ULTRACET Tramadol HydrochlorideAcetaminophen Versus ULTRAM Tramadol Hydrochloride Versus Placebo in Patients With Pain After Oral Surgery
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Comparison of the Efficacy and Safety of ULTRACET Tramadol HClAcetaminophen Versus ULTRAM Tramadol HCl Versus Placebo in Subjects With Pain Following Oral Surgery
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 two analgesic treatment regimens as compared to placebo in patients experiencing pain after oral surgery Tramadol hydrochlorideacetaminophen is approved to treat acute pain This study will evaluate the effectiveness and safety of tramadol hydrochlorideacetaminophen compared with tramadol hydrochloride alone compared with placebo as a pain medication in the treatment of pain following oral surgery
Detailed Description:
While other studies have shown the effectiveness and safety of tramadolacetaminophen and of tramadol alone in treating pain following oral surgery a direct comparison of the two treatments within the same study at these dose levels has not be performed This is a single-center randomized double-blind active- and placebo-controlled single-dose parallel-group study of adult patients who undergo oral surgery for removal of two or more impacted third molars Patients who have at least moderate pain within 5 hours after surgery will be given a single oral dose of 2 capsules of study medication Patients will be equally assigned to receive a total dose of either tramadol HCl 75 mgacetaminophen 650 mg or tramadol HCl 100 mg or placebo Patients will be asked about the intensity of the current pain and pain relief from the starting pain at 30 minutes and at 1 2 3 4 5 and 6 hours after taking the study medication Patients will also be given two stopwatches that will be started once medication has been taken Patients will stop the first stopwatch when they first notice any pain decrease they will stop the second stopwatch when they notice meaningful pain relief The primary efficacy endpoints are summary measures of hourly patient reported pain relief PAR and pain intensity scores total PAR TOTPAR sum of hourly pain intensity differences PIDs from baseline SPID and sum of hourly PAR plus hourly PIDs from baseline SPRID The study hypothesis is that pain relief with tramadol HClacetaminophen ULTRACET is superior to pain relief from tramadol HCl ULTRAM alone after oral surgery and the combination is well tolerated
2 capsules total dose either tramadol HCl 75 milligramsacetaminophen 650 milligrams tramadol HCl 100 milligrams or matching placebo taken one time orally all study medication is over-capsulated to match
2 capsules total dose either tramadol HCl 75 milligramsacetaminophen 650 milligrams tramadol HCl 100 milligrams or matching placebo taken one time orally all study medication is over-capsulated to match
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