Status:
UNKNOWN
Development of a Bedside Pain Assessment Kit for Postherpetic Neuralgia
Lead Sponsor:
Analgesic Solutions
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Neuralgia
Herpes Zoster
Eligibility:
All Genders
40-85 years
Brief Summary
Post herpetic neuralgia (PHN) is an undertreated condition. It is a type of neuropathic pain (NP), or pain caused by abnormal activity of sensory nerves. Its mechanisms are not fully understood, and m...
Detailed Description
We hypothesize: (a) that a Bedside Sensory Testing Kit for PHN can be designed such that it works efficiently with Subjects and Investigators, is tolerated well by Subjects, and is statistically relia...
Eligibility Criteria
Inclusion
- Subject is between 40 and 85 years old.
- Physician documentation of history of postherpetic neuralgia must be provided; pain persisting more than 3 months/90 days after a patient's vesicular rash (shingles) has healed.
- Subject is able to speak, read and write in English and comply with all study procedures;
- Subject is willing to voluntarily sign and date an Informed Consent Form, approved by an IRB, prior to the conduct of any study-specific procedures;
- Subject must be willing to abstain from PRN (as needed) pain medicine for 12 hours prior to the study but may continue their standing doses of pain medicine.
Exclusion
- Subject is pregnant and/or breast-feeding.
- Subjects with additional sources of chronic pain will not be allowed if the severity of pain in additional locations is severe enough to compromise assessment of PHN pain. This will be left to the Investigator's discretion.
- Subject has a medical condition, other than PHN, that is not well-controlled with treatment; or the subject has any clinically significant condition that would, in the opinion of the investigator, preclude study participation, interfere with the assessment of pain, or pose unacceptable risk to the participant.
- Subject has been enrolled in another study within 30 days.
- Subject has a known contact allergy to surgical skin markers.
- In the judgment of the investigator, the subject has a psychiatric or psychological disorder that would interfere with the completion of the study, confound the study results, or pose patient risk.
- Subject has neuropathy or nerve fiber disease other than PHN (e.g., diabetic peripheral neuropathy).
Key Trial Info
Start Date :
July 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01166295
Start Date
July 1 2010
End Date
November 1 2010
Last Update
August 5 2010
Active Locations (1)
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1
Analgesic Solutions
Natick, Massachusetts, United States, 01760