Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236535
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-10-07
Brief Title:
A Study of the Efficacy and Safety of Tramadol HClAcetaminophen Hydrocodone BitartrateAcetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament
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 Tramadol HClAcetaminophen Versus Hydrocodone BitartrateAcetaminophen Versus Placebo in Subjects With Acute Musculoskeletal Pain
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 acute musculoskeletal pain Patients who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe enough to require prescription pain relief medication will be randomized to receive either tramadol HClacetaminophen hydrocodone bitartrateacetaminophen or placebo
Detailed Description:
Tramadol HClacetaminophen is approved for short-term five days or less management of acute pain The combination of tramadol HClacetaminophen provides a more rapid onset of action compared with tramadol HCl alone and a longer duration of action than acetaminophen alone Therefore the combination of tramadol HClacetaminophen may be effective for the treatment of acute musculoskeletal pain The current study is a multicenter randomized double-blind inpatientoutpatient active-controlled placebo-controlled parallel-group study Patients who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe enough to require prescription medication will be enrolled Patients will be randomized to receive either oral tramadol HClacetaminophen hydrocodone bitartrateacetaminophen or placebo Patients will receive 2 capsules tramadol HClacetaminophen 375325 milligrams or 1 capsule hydrocodone bitartrateacetaminophen 75650 milligrams 1 capsule placebo or 2 capsules placebo Patient may take 1 or 2 capsules up to 4 times daily as needed but no more than 8 capsules per day for 5 daysThe first dose of study medication will be given at the study site Patients will complete a Pain Visual Analog Scale Pain Relief Rating Scale and Pain Intensity Scale at 1 2 3 and 4 hours after the first dose of study medication On Day 1 after the 4-hour evaluations patients will be dispensed study medication for use throughout the rest of the study Patients will also evaluate and record in a daily diary the pain intensity ratings and pain relief scores for Days 1-5 of the double-blind phase At the final visit patients will complete a Pain Intensity Scale and Pain Relief Rating Scale an Activity Impairment Assessment and a Subject Overall Medication Assessment At the first dose patients are dispensed 2 capsules of study medication Thereafter patients may take 1 or 2 capsules of study medication orally up to 4 times per day as needed for pain but no more than 8 capsules per day The objective of this study is to compare the pain-relieving effectiveness and safety of tramadol HClacetaminophen versus hydrocodone bitartrateacetaminophen versus placebo for the treatment of acute musculoskeletal pain from an ankle sprain with a partial ligament tear
2 capsules tramadol HClacetaminophen 375325 milligrams or 1 capsule hydrocodone bitartrateacetaminophen 75650 milligrams 1 capsule placebo or 2 capsules placebo patient may take 1 or 2 capsules orally up to 4 times daily as needed but no more than 8 capsules per day for 5 days
2 capsules tramadol HClacetaminophen 375325 milligrams or 1 capsule hydrocodone bitartrateacetaminophen 75650 milligrams 1 capsule placebo or 2 capsules placebo patient may take 1 or 2 capsules orally up to 4 times daily as needed but no more than 8 capsules per day for 5 days
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