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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pennsaid Phase I | Active Comparator | 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. |
|
| Placebo Phase I | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pennsaid | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianren Mao, M.D., Ph.D. | DACCPM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Center for Translational Pain Research | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pennsaid Phase I, Placebo Phase II | Phase I: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily). Washout: 1 week, applying nothing. Phase II: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily). |
| FG001 | Placebo Phase I, Pennsaid Phase II | Phase I: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily). Washout: 1 week, applying nothing. Phase II: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I (2 Weeks) |
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| Washout Period (1 Week) |
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| Phase II (2 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pennsaid Phase I | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only subjects who completed both phases of the crossover study were considered for data analysis. | Posted | Mean | Standard Deviation | Visual Analog Scale | 2 weeks. |
|
Adverse event data was collected over the length of a subject's participation in the study (5 weeks).
Due to the study design, subjects who withdrew before completing the entire study were not considered for any treatment period that they did not participate in due to drop out or withdrawl. Subjects who completed only part of a treatment period were considered.These numbers may differ from the total number enrolled in the study for this reason.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pennsaid | Pennsaid (20-40 drops; 2-4 times daily for 2 weeks). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jianren Mao | Massachusetts General Hospital | 6177246102 | mghpainresearch@partners.org |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D051474 | Neuralgia, Postherpetic |
| D012019 | Reflex Sympathetic Dystrophy |
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo (2.3% DMSO solution) | Drug |
|
|
| 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. | 2 weeks |
| Positive Drug Screen |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| Placebo Phase I |
Placebo lotion (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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
All subjects who recieved Pennsaid lotion in either Phase I or II were considered. |
|
|
|
| Secondary | 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. | Only subjects | Posted | Mean | Standard Deviation | Visual Analog Scale | 2 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Visual Analog Scale | 2 weeks |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Placebo | Placebo lotion (20-40 drops; 2-4 times daily for 2 weeks). | 0 | 33 | 0 | 33 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001342 | Autonomic Nervous System Diseases |