Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347724
Status:
COMPLETED
Last Update Posted:
2012-06-21
First Post:
2006-07-02
Brief Title:
A Study Comparing the Effectiveness and Safety of Extended-release Tramadol Versus Placebo in the Treatment of Chronic Low Back Pain
Sponsor:
Bausch Health Americas Inc
Organization:
Bausch Health Americas Inc
Study Overview
Official Title:
Double-blind Randomized Placebo-controlled Parallel Group Comparison of the Efficacy and Safety of Extended Release Tramadol Tramadol ER 300 mg and 200 mg to Placebo in the Treatment of Chronic Low Back Pain
Status:
COMPLETED
Status Verified Date:
2012-06
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 compare the analgesic efficacy of oral once-daily tramadol ER 300 mg and 200 mg to placebo in patients with moderate to severe chronic low back pain requiring daily analgesic treatment The study hypothesis is that tramadol ER is effective in the treatment of moderate to severe chronic low back pain
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 IR tramadol necessitates every 4-6 hour dosing in order to maintain optimum levels of analgesia in chronic pain The study medication in this study is a once-daily extended release ER tramadol formulation This is a multicenter double-blind randomized placebo-controlled parallel-group study At the Screening Visit patients eligible for study participation by medical history physical exam and other evaluations will enter a 2-7 day washout period during which time analgesics will not be allowed At Visit 2 patients with a pain intensity 40 mm on a 100 mm visual analog scale VAS and who meet all other eligibility criteria will be admitted into a 3-week open-label run-in period during which time they will receive tramadol ER 100 mg once daily QD for at least 3 days On Day 4 the dose will be increased to tramadol ER 200 mg QD based on tolerability Patients must be maintained on a minimum dose of tramadol 200 mg QD by the beginning of Week-2 Visit 3 the dose may be increased to tramadol ER 300 mg QD at Visit 3 based on tolerability Patients must increase their tramadol ER dose to 300 QD by the beginning of Week - 1 Visit 4 this dose must be maintained for one week Patients with pain unresponsive to appropriate dose adjustments or with unacceptable side effects will be discontinued from the study and an alternative analgesic therapy will be initiated Patients receiving tramadol ER 300 mg QD at the end of the run-in period Visit 5 Week 0 will enter a 12-week double-blind period during which they will be randomized to receive tramadol ER 300 mg tramadol ER 200 mg or placebo QD No dose adjustments will be permitted during the double-blind period of the study Patients will return for safety and efficacy evaluations at Weeks 1 2 4 8 and 12 or early termination Study medication will be discontinued at Week 12 and patients will return after one week for a post-treatment visit Week 13
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