Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-31 @ 2:53 PM
Study NCT ID:
NCT00424593
Status:
COMPLETED
Last Update Posted:
2009-11-20
First Post:
2007-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Duloxetine Versus Placebo in Chronic Low Back Pain
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain
Status:
COMPLETED
Status Verified Date:
2009-11
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 primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition.
Whether duloxetine once daily can help patients with Chronic Low Back Pain.
Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.
Whether duloxetine once daily can help patients with Chronic Low Back Pain.
Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| F1J-MC-HMEN | None | None | View |