Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130962
Status:
COMPLETED
Last Update Posted:
2005-10-03
First Post:
2005-08-15
Brief Title:
ALGRX 4975 in the Treatment of Patients With Mortons Neuroma
Sponsor:
AlgoRx Pharmaceuticals
Organization:
AlgoRx Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Trial of ALGRX 4975 in Subjects With Painful Intermetatarsal Neuroma
Status:
COMPLETED
Status Verified Date:
2005-08
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:
Subjects will have painful primary or post-operative intermetatarsal neuroma Study drug or placebo will be injected into the space containing the neuroma Subjects will complete weekly assessments for severity of foot pain a brief pain inventory and the amount of pain medication taken Subjects will be seen for a screening visit a treatment visit and two follow-up visits after treatment The last scheduled visit is one month after treatment Some subjects may be followed by monthly telephone interviews to assess their level of pain over the six-month period following treatment
Detailed Description:
Subjects will have painful primary or post-operative intermetatarsal neuroma Each subject will be randomly allocated to receive either ALGRX 4975 or placebo in a 11 ratio Study drug or placebo will be injected into the intermetatarsal space containing a painful neuroma Subjects will complete weekly assessments for the Average Foot Pain Severity the 7 Interference Items of the BPI and the number of analgesic units taken Some subjects may be followed by monthly telephone interviews to assess their level of pain over the six-month period following treatment
Plasma concentrations will be assessed pre-dose and post dose at 5 10 15 20 30 and 45 min and at 1 15 2 25 3 and 4 hours
Safety will be assessed at baseline and during the study with adverse events all visits vital signs Visit 2 pre and post-injection and Visit 3 or at early termination and laboratory assessments hematology chemistry urinalysis and ECG Screening and Visit 3 or at early termination The injection site will be examined and assessed by a 6-point scale for erythema edema and hemorrhage before the injection and at 1 2 and 4 hours after the injection A pain on injection NRS will be assessed immediately post- injection at 15 30 and 45 minutes and 1 2 3 and 4 hours after study drug administration A sensory examination of the foot will be performed before the injection and 4 hours after the injection and at the completion of the study If a subject has injection pain the foot may be wrapped in ice for up to 20 minutes analgesic medication may be provided
Plasma concentrations will be assessed pre-dose and post dose at 5 10 15 20 30 and 45 min and at 1 15 2 25 3 and 4 hours
Safety will be assessed at baseline and during the study with adverse events all visits vital signs Visit 2 pre and post-injection and Visit 3 or at early termination and laboratory assessments hematology chemistry urinalysis and ECG Screening and Visit 3 or at early termination The injection site will be examined and assessed by a 6-point scale for erythema edema and hemorrhage before the injection and at 1 2 and 4 hours after the injection A pain on injection NRS will be assessed immediately post- injection at 15 30 and 45 minutes and 1 2 3 and 4 hours after study drug administration A sensory examination of the foot will be performed before the injection and 4 hours after the injection and at the completion of the study If a subject has injection pain the foot may be wrapped in ice for up to 20 minutes analgesic medication may be provided
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