Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00496457
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2007-06-22
Brief Title:
Efficacy Study With 500 mg QD of TRO19622 vs Placebo in Patients With Painful Peripheral Diabetic Neuropathy
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Double-Blind Randomized Multicenter Study With 500 mg QD of TRO19622 Versus Placebo in Patients With Painful Peripheral Diabetic Neuropathy
Status:
COMPLETED
Status Verified Date:
2016-11
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 purpose of this study is to assess the efficacy and safety of TRO19622 administered PO daily for 6 weeks compared to placebo administered PO daily in patients with painful peripheral diabetic neuropathy
Detailed Description:
Diabetic peripheral neuropathic pain DPNP affects approximately 11 of patients with diabetic peripheral neuropathy DPN Diabetic neuropathy as the underlying disease is the most common long-term complication of diabetes mellitus estimated to be experienced by a majority of patients at least in a mild manner
Many patients with DPNP do not respond adequately to any individual treatment option None of the various treatments used can be considered a cure As a result although a variety of drugs are available for the treatment of diabetic neuropathic pain there is a strong need to develop new drugs with greater efficacy andor fewer adverse effects
The primary objective of the study is to compare the effect of TRO19622 versus placebo on the 24h neuropathic pain scores during the last 7 days of the 6-week treatment period
Secondary objectives are to compare the efficacy on neuropathic pain impact on emotional functioning safety profile pain time course and response rate of TRO19622 versus placebo Additionally the pharmacokinetics of TRO19622 will be assessed
Many patients with DPNP do not respond adequately to any individual treatment option None of the various treatments used can be considered a cure As a result although a variety of drugs are available for the treatment of diabetic neuropathic pain there is a strong need to develop new drugs with greater efficacy andor fewer adverse effects
The primary objective of the study is to compare the effect of TRO19622 versus placebo on the 24h neuropathic pain scores during the last 7 days of the 6-week treatment period
Secondary objectives are to compare the efficacy on neuropathic pain impact on emotional functioning safety profile pain time course and response rate of TRO19622 versus placebo Additionally the pharmacokinetics of TRO19622 will be assessed
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 |
|---|---|---|---|
| EudraCT Number 2006-004545-42 | None | None | None |
| TRO19622 CLEQ 1104-1 | OTHER | trophos id | None |