An interventional study of Pennsaid and Placebo (2.3% DMSO solution) in Neuralgia, Postherpetic Neuralgia and Reflex Sympathetic Dystrophy, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-02-06.
Sponsored by Massachusetts General Hospital · Not applicable and Interventional
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.
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).
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 35 is below the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Exclusion Criteria:
Pennsaid (20-40 drops; 2-4 times daily) Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects.
Drug: Pennsaid
Study subject will topically apply placebo lotion (20-40 drops) 2-4 times daily to the painful area for the next two weeks. The dose titration will be based on the size of painful area (approximately 10 drops for every 4 square inches). Subjects will be asked to fill in a daily pain diary and report any side effects to the research center. A phone number and a beeper number will be provided to subjects.
Drug: Placebo (2.3% DMSO solution)
Also known as: Pennsaid topical 1.5% diclofenac, a non-steroid anti-inflammatory drug
Also known as: Placebo (2.3% DMSO solution; 20-40 drops; 2-4 times daily).
VAS After Treatment
Subjects rated their pain using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion. The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study.
Time frame: 2 weeks.
Clinical Neuropathic Pain Features- Burning After Treatment
Subjects rated their "burning pain" using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion. The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study.
Time frame: 2 weeks
Clinical Neuropathic Pain Features- Constant Pain and Hypersensitivity After Treatment
Subjects rated their "constant pain" and "hypersensitivity" using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion. The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study.
Time frame: 2 weeks
| Milestone | Pennsaid Phase I, Placebo Phase II | Placebo Phase I, Pennsaid Phase II |
|---|---|---|
| Started | 18 | 17 |
| Completed | 16 | 14 |
| Not completed | 2 | 3 |
| Withdrew: Medication exclusion | 1 | 1 |
| Withdrew: Wrong pain type | 1 | 0 |
| Withdrew: Positive drug screen | 0 | 2 |
| Milestone | Pennsaid Phase I, Placebo Phase II | Placebo Phase I, Pennsaid Phase II |
|---|---|---|
| Started | 16 | 14 |
| Completed | 16 | 14 |
| Not completed | 0 | 0 |
| Milestone | Pennsaid Phase I, Placebo Phase II | Placebo Phase I, Pennsaid Phase II |
|---|---|---|
| Started | 16 | 14 |
| Completed | 15 | 13 |
| Not completed | 1 | 1 |
| Withdrew: Skin sensitivity | 0 | 1 |
| Withdrew: Medication exclusion | 1 | 0 |
Subjects rated their pain using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion. The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study.
| Visual Analog Scale | Pennsaid | Placebo |
|---|---|---|
| VAS After Treatment | 4.9 ± 1.9 | 5.6 ± 2.1 |
Subjects rated their "burning pain" using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion. The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study.
| Visual Analog Scale | Pennsaid | Placebo |
|---|---|---|
| Clinical Neuropathic Pain Features- Burning After Treatment | 2.9 ± 2.6 | 4.3 ± 2.8 |
Subjects rated their "constant pain" and "hypersensitivity" using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion. The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study.
| Visual Analog Scale | Pennsaid | Placebo |
|---|---|---|
| Clinical Neuropathic Pain Features- Constant Pain and Hypersensitivity After Treatment | 4.0 ± 2.9 | 4.3 ± 2.8 |
Collected over Adverse event data was collected over the length of a subject's participation in the study (5 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pennsaid | — | 0/32 (0%) | 0/32 (0%) |
| Placebo | — | 0/33 (0%) | 0/33 (0%) |
| Age, Categorical(Participants) | Pennsaid Phase I | Placebo Phase I | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 15 | 32 |
| >=65 years | 1 | 2 | 3 |
| Gender(Participants) | Pennsaid Phase I | Placebo Phase I | Total |
|---|---|---|---|
| Female | 9 | 8 | 17 |
| Male | 9 | 9 | 18 |
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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