Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210847
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-13
Brief Title:
A Study Comparing the Effectiveness and Safety of Tramadol HClAcetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients
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 Tramadol HClAcetaminophen for the Treatment of Painful Diabetic Neuropathy
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-reieiving effects and safety of tramadol HClacetaminophen as compared to placebo in patients experiencing painful diabetic neuropathy Treatment of neuropathic pain often requires the use of more than one medication The pain-relieving potential of tramadol HClacetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication Patients who experience painful diabetic neuropathy will be enrolled in this study
Detailed Description:
Previous studies have shown that tramadol HCl is effective in painful diabetic neuropathy The treatment of neuropathic pain often requires the use of more than one medication working through different mechanisms of action to provide the best pain relief The pain-relieving potential of tramadol HCl acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication This is a multicenter randomized double-blind placebo-controlled parallel group study Patients who experience painful diabetic neuropathy will be enrolled There will be a period of up to 3 weeks during which patients will stop taking medications not allowed by the study A 7-day baseline period will follow during which time patients will call into an Interactive Voice Response IVR system every night at bedtime to record daily assessments including average daily pain and sleep interference Patients who enter the double-blind portion of the study will be randomized like with the toss of a coin to receive either tramadol HClacetaminophen or placebo The dose of tramadol HClacetaminophen or placebo will be gradually increased until the doctor determines the patient is taking an adequate dose up to 1 or 2 tablets 4 times per day but not more than 8 tablets per day Every night at bedtime during the double-blind phase patients will call the IVR system to report assessments of average daily pain sleep interference and the number of tablets of study medication taken that day At the end of the study patients will be tapered off their study medication The objective of this study is to compare the analgesic effectiveness and safety of tramadol HClacetaminophen versus placebo for the treatment of painful diabetic neuropathy
1 or 2 tramadol HCl 375 milligramsacetaminophen 325 milligrams combination tablets or matching placebo by mouth up to 4 times a day for 66 days
1 or 2 tramadol HCl 375 milligramsacetaminophen 325 milligrams combination tablets or matching placebo by mouth up to 4 times a day for 66 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