NCT00611949

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

9.6 years

First QC Date

January 29, 2008

Last Update Submit

December 17, 2015

Conditions

Neuropathic Pain

Keywords

Geranium oilNeuropathyShinglesHerpes zoster

Outcome Measures

Primary Outcomes (1)

  • Pain relief

    2 hrs. post-application

Secondary Outcomes (1)

  • Response to therapy at one hour, defined as reduction of pain summed over the first hour, compared between the two oils.

    1 hr. post-application

Study Arms (2)

1 Geranium Oil

ACTIVE COMPARATOR
Other: Geranium oil

2 Geramium Oil

ACTIVE COMPARATOR
Other: Geranium oil

Interventions

Geranium oilOTHER

2 applications of topical oil per week for 2 weeks

1 Geranium Oil2 Geramium Oil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

NeuralgiaHerpes Zoster

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Frank Greenway, MD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Medical Doctor

Study Record Dates

First Submitted

January 29, 2008

First Posted

February 11, 2008

Study Start

May 1, 2002

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

US(1)