Comparison of 2 Vials of Components of a Synthetic Geranium Oil

Neuropathic Pain Clinical Trial

Official title: EPT 101: New Geranium Oil Formulation for the Treatment of Neuropathy Pain

Status Completed

Clinical Trial Summary

The purpose of this study is to determine which component of an artificial geranium oil helps to reduce your neuropathy pain.

Clinical Trial Description

EPT 101 is a double-blind successive crossover study designed to determine which components of a synthetic geranium oil provide analgesic relief, with the objective of identifying and purifying the active substance. This is not a hypothesis-generating trial, nor is it confirming a hypothesis. The trial uses human volunteers in an efficacy-directed decomposition of a complex mixture.

Patients with a diagnosis of neuralgia or neuropathy who respond to geranium oil will test two vials of components of a synthetic geranium oil for application to the maximally painful area in succession. They will treat their condition in the clinic and fill out a patient diary on separate days. The primary objective is the patient opinion of which vial has greatest analgesic efficacy. Efficacy will be measured primarily by reduction in pain intensity summed over the first two hours, compared with the pain intensity during the 30 minutes preceding application.

Following the comparison of the first two vials, the vial judged efficacious will be decomposed into two further vials and the patients will repeat the evaluation described above. At least eight pair-wise comparisons will be required to determine and confirm which of the 100+ ingredients of a synthetic geranium oil are analgesic, provided there is only one such ingredient. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

• NCT number: NCT00611949
• Study type: Interventional
• Source: Pennington Biomedical Research Center
• Status: Completed
• Phase: N/A
• Start date: May 2002
• Completion date: December 2011