Effects of Pennsaid on Clinical Neuropathic Pain

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Neuralgia; Postherpetic Neuralgia; Reflex Sympathetic Dystrophy; Complex Regional Pain Syndrome (CRPS)	Drug: Pennsaid; Drug: Placebo (2.3% DMSO solution)	Not Applicable

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).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	35 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title:	Effects of Pennsaid on Clinical Neuropathic Pain
Study Start Date :	November 2011
Actual Primary Completion Date :	March 2013
Actual Study Completion Date :	January 2016

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 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.	Drug: Pennsaid; Other Names: Pennsaid topical 1.5% diclofenac; a non-steroid anti-inflammatory drug
Placebo Comparator: Placebo Phase I; 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); Other Name: Placebo (2.3% DMSO solution; 20-40 drops; 2-4 times daily).

Outcome Measures

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Primary Outcome Measures :

1. VAS After Treatment [ Time Frame: 2 weeks. ]

   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.

Secondary Outcome Measures :

1. Clinical Neuropathic Pain Features- Burning After Treatment [ Time Frame: 2 weeks ]

   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.

2. Clinical Neuropathic Pain Features- Constant Pain and Hypersensitivity After Treatment [ Time Frame: 2 weeks ]

   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Subject will be between 18 and 80 years of age.
2. Subject has not been on Pennsaid or other topical non-steroid anti-inflammatory drugs for at least one month.
3. Subject agrees to make no change in his/her current pain medications during the entire study period. This requirement will ensure that valid comparisons of primary and secondary measures can be made before and after the study.
4. Subject has a VAS pain score of 4 or above at the beginning of the study.
5. Subject has had a neuropathic pain condition such as those listed above for at least three months. This requirement is to avoid clinical uncertainty from an unstable pain condition and to minimize the study variation.
6. Female subjects of childbearing age must have a negative urine pregnancy test at the initial visit.

Exclusion Criteria:

1. Subject has documented severe liver or renal disease that will affect the elimination of Pennsaid or is subject to the adverse effect of Pennsaid on these organs. (Renal dysfunction is defined as eGFR < 60. Hepatic dysfunction is defined as LFTs ≥ 3X ULN.)
2. Subject has pending litigation related to the neuropathic pain condition.
3. Subject has active skin lesion or open wound at the site of Pennsaid application (e.g., active shingles with skin lesions).
4. Subject is pregnant or lactating.
5. Subject has scar tissue or sensory deficit at the site of QST.
6. Subject is allergic to diclofenac or has cross-sensitivity to other non-steroid anti-inflammatory drugs.
7. Subject has a positive urine (illicit) drug test.
8. Subjects who experience asthma, urticaria or an allergic type reaction when taking aspirin or NSAIDs.
9. Subjects undergoing coronary artery bypass surgery.
10. Subject with a known history of cardiovascular disease, ulcer, gastrointestinal bleed or impaired renal function.
11. Subjects currently using NSAIDS.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
MGH Center for Translational Pain Research
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:	Jianren Mao, M.D., Ph.D.	DACCPM

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Jianren Mao, MD, PhD, Vice Chair Research, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01508676 History of Changes
Other Study ID Numbers:	2011p000897
First Posted:	January 12, 2012
Results First Posted:	February 6, 2017
Last Update Posted:	February 6, 2017
Last Verified:	December 2016

Keywords provided by Jianren Mao, MD, PhD, Massachusetts General Hospital:

neuropathic pain; postherpetic neuralgia; complex regional pain syndrome; reflex sympathetic dystrophy

Additional relevant MeSH terms:

Neuralgia; Neuralgia, Postherpetic; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Pain; Neurologic Manifestations; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Signs and Symptoms; Autonomic Nervous System Diseases; Pharmaceutical Solutions	Anti-Inflammatory Agents; Diclofenac; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action