Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325858
Status:
COMPLETED
Last Update Posted:
2012-08-27
First Post:
2006-05-11
Brief Title:
A Study Comparing the Effectiveness and Safety of Varying Dose Strengths 100 200 300 and 400 mg of Extended-release Tramadol HCl With Placebo for the Treatment of OsteoarthritisOA of the Knee andor Hip
Sponsor:
Bausch Health Americas Inc
Organization:
Bausch Health Americas Inc
Study Overview
Official Title:
Double-Blind RandomizedDose-Ranging Parallel-Group Comparison Of The Efficacy And Safety Of Extended-Release Tramadol HydrochlorideTramadol HCl ER100 Mg 200 Mg 300 Mg And 400 Mg With Placebo In The Treatment Of Osteoarthritis Of Knee AndOr Hip
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the effectiveness of multiple doses of once daily tramadol HCl ER 100 200 300 and 400 mg to placebo in patients with moderate to severe pain due to OA The study hypothesis is that tramadol HCl ER is safe and effective in the treatment of patients with moderate to severe pain due to OA
Detailed Description:
Immediate release IR tramadol has demonstrated efficacy in several pain conditions including obstetrical gynecological orthopedic abdominal and oral surgery The short elimination half-life of tramadol IR necessitates every 4-6 hour dosing to maintain optimal levels of analgesia in chronic pain The study medication in this study is a once-daily extended-release tramadol formulation This is a 12-week multi-center double-blind randomized dose-ranging parallel-group fixed-dose placebo-controlled study Patients with OA Functional Class I-III of the knee or hip index joint are eligible for participation if appropriate criteria are met During a 2-7 day washout period the use of all analgesic medications will be discontinued Eligible patients experiencing moderate to severe pain 40 mm on a 100 mm visual analog scale in the index joint to be evaluated and who meet all other study criteria will enter in a 2-weekdouble-blind titration period During this period patients will be randomly assigned to receive treatment with tramadol HCl ER 100 mg 200 mg 300 mg 400 mg or placebo once a day Patients will be titrated to their assigned dose between study days 1 - 15 and will continue at that dose for the remainder of the study Week 12 Efficacy and safety evaluations will be collected at study visits occurring at Weeks 1 2 3 6 9 and 12 or at early termination Study medication will be discontinued at Week 12 and patients will return after 1 week for a post-treatment visit Week 13 Patients with unmanageable pain or with unacceptable side effects will be discontinued from the study and alternate analgesic therapy initiated as appropriate
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