ALGRX 4975 in the Treatment of Patients With Morton's Neuroma
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|ClinicalTrials.gov Identifier: NCT00130962|
Recruitment Status : Completed
First Posted : August 17, 2005
Last Update Posted : October 3, 2005
|Condition or disease||Intervention/treatment||Phase|
|Neuroma||Drug: ALGRX 4975||Phase 2|
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 1:1 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, 1.5, 2, 2.5, 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Trial of ALGRX 4975 in Subjects With Painful Intermetatarsal Neuroma|
|Study Start Date :||September 2004|
|Estimated Study Completion Date :||February 2006|
- Weekly average foot pain severity scores
- The sum of weekly average foot pain severity scores
- Interference item scores of the Brief Pain Inventory
- Weekly number of analgesic units taken
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130962
|United States, Maryland|
|Crossroads Research, Inc.|
|Owings Mills, Maryland, United States, 21117|
|United States, Utah|
|Jean Brown Research|
|Salt Lake City, Utah, United States, 84124|
|Principal Investigator:||Eric Diamond, D.P.M.||Crossroads Research, Inc.|