Effects of Pennsaid on Clinical Neuropathic Pain

December 13, 2016 updated by: Jianren Mao, MD, PhD, Massachusetts General Hospital

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.
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.
Other Names:
  • Placebo (2.3% DMSO solution; 20-40 drops; 2-4 times daily).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

2 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks
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.

2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

December 13, 2016

Last Verified

December 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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