NCT01508676

Effects of Pennsaid on Clinical Neuropathic Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if the drug Pennsaid (Diclofenac) can help reduce pain felt by people with chronic nerve pain. The drug will be used 2-4 times each day for 2 weeks. The U.S. Food and Drug Administration (FDA) has approved Pennsaid to treat osteoarthritis (bone pain), but the FDA has not approved Pennsaid to treat neuropathic (nerve) pain. The research study will compare Pennsaid to placebo.

Detailed description

The research study will compare Pennsaid to placebo. The placebo looks like Pennsaid, but it doesn't contain any Pennsaid. The investigators use placebos in research to see if the results are due to the study drug or to other reasons. At some time during the study the investigators will give the patient Pennsaid. At another time, the investigators will give the patient placebo. The investigators are using Quantitative Sensory Testing (QST), which is temperature testing before and after using the study drug to see if Pennsaid is helpful in reducing people's nerve pain. In this test, a small metal plate, about the size of a matchbox, is put on the area where the patient has pain. The plate is connected to a computer that can warm or cool the plate. The patient will use a computer mouse button to tell us when the plate feels warm. The QST machine is approved by the Food and Drug Administration (FDA). It is often used by nerve doctors to see if a person has neuropathy (pain caused by damage to a nerve).

Conditions

• Neuralgia
• Postherpetic Neuralgia
• Reflex Sympathetic Dystrophy
• Complex Regional Pain Syndrome (CRPS)

Interventions

Type	Name	Description
DRUG	Pennsaid
DRUG	Placebo (2.3% DMSO solution)

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-03-01
• Completion: 2016-01-01
• First posted: 2012-01-12
• Last updated: 2017-02-06
• Results posted: 2017-02-06

Locations

1 site across 1 country: United States