Comparison of 2 Vials of Components of a Synthetic Geranium Oil

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alok K. Gupta, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00611949
First received: January 29, 2008
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention
Neuropathic Pain
Other: Geranium oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: EPT 101: New Geranium Oil Formulation for the Treatment of Neuropathy Pain

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Pain relief [ Time Frame: 2 hrs. post-application ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response to therapy at one hour, defined as reduction of pain summed over the first hour, compared between the two oils. [ Time Frame: 1 hr. post-application ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: May 2002
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Geranium Oil Other: Geranium oil
2 applications of topical oil per week for 2 weeks
Active Comparator: 2 Geramium Oil Other: Geranium oil
2 applications of topical oil per week for 2 weeks

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • You are eligible to participate in this study if you have completed the study EPT 100 and geranium oil relieves your neuropathy pain successfully.

Exclusion Criteria:

  • You are ineligible to participate in this study if you have completed the study EPT 100 and geranium oil does not relieve your neuropathy pain successfully
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611949

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Frank Greenway, MD Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Alok K. Gupta, Principal INvestigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00611949     History of Changes
Other Study ID Numbers: PBRC21013, EPT 101
Study First Received: January 29, 2008
Last Updated: May 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Geranium oil
Neuropathy
Shingles
Herpes zoster

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014