Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449176
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
2007-03-16
Brief Title:
A Study to Evaluate the Effectiveness and Safety of Tapentadol CG5503 Extended Release ER in Patients With Moderate to Severe Chronic Low Back Pain
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Placebo- and Active-Control Parallel-arm Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release ER in Subjects With Moderate to Severe Chronic Low Back Pain
Status:
COMPLETED
Status Verified Date:
2012-04
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 trial is to evaluate the effectiveness level of pain control and safety of orally administrated tapentadol CG5503 Extended Release ER base at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain of the lower back in comparison with placebo and Oxycodone Controlled Release CR
Detailed Description:
The primary objective of this randomized study medication assigned to patients by chance double-blind neither patient nor investigator knows the study medication phase III placebo and active controlled trial is to evaluate the efficacy and safety of orally administered tapentadol CG5503 Extended Release ER base at doses 100-250 mg twice daily in patients with moderate to severe chronic pain of the lower back The study is being conducted for registration and approval of tapentadol CG5503 in the US and outside US The trial will consist of five periods screening to assess eligibility washout 3-7 days with determination of baseline pain intensity titration of dose over 3 weeks to the optimal individual level maintenance investigational drug intake for 12 weeks with adjustments allowed and follow-up 2 weeks post treatment discontinuation The study hypothesis is that the study drug will be more effective than placebo in reducing patients pain intensity The Secondary objectives include the collection of pharmacokinetic related to how the body uses the drug information for dose verification The trial objectives will be assessed by comparing the baseline pain level to the level of week 12 of the maintenance phase This will be done by looking at the patients pain diary information Titrate tapentadol CG5503 ER extended release in 50 mg steps to patients optimal dose ranging between 100mg and 250mg twice a day Oxycodone CR controlled release 20mg to 50mg twice a day Placebo no active ingredients All doses of trial treatment will be taken orally with or without food for a maximum timeframe of 15 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R331333PAI3011 | OTHER | Johnson Johnson Pharmaceutical Research Development LLC | None |