Effects of Pennsaid on Clinical Neuropathic Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01508676
First received: January 4, 2012
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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 Intervention
Neuralgia
Postherpetic Neuralgia
Reflex Sympathetic Dystrophy
Complex Regional Pain Syndrome (CRPS)
Drug: Pennsaid topical 1.5% diclofenac
Drug: Placebo (2.3% DMSO solution)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Effects of Pennsaid on Clinical Neuropathic Pain

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Effect of Pennsaid on Clinical Neuropathic Pain [ Time Frame: Five weeks. ] [ Designated as safety issue: Yes ]
    Four times throughout the study the subject will fill out questionnaires, SF-36s, and take QSTs.


Estimated Enrollment: 48
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pennsaid
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 topical 1.5% diclofenac
Pennsaid (20-40 drops; 2-4 times daily) and 2) placebo (2.3% DMSO solution; 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
  • a non-steroid anti-inflammatory drug
Placebo Comparator: Placebo
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)
Placebo (2.3% DMSO solution; 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:
  • Placebo (2.3% DMSO solution; 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.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508676

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

No publications provided

Responsible Party: Jianren Mao, MD, PhD, Vice Chair Research, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01508676     History of Changes
Other Study ID Numbers: 2011p000897
Study First Received: January 4, 2012
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
neuropathic pain
postherpetic neuralgia
complex regional pain syndrome
reflex sympathetic dystrophy

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Reflex Sympathetic Dystrophy
Complex Regional Pain Syndromes
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Autonomic Nervous System Diseases
Anti-Inflammatory Agents
Diclofenac
Dimethyl Sulfoxide
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents
Free Radical Scavengers
Antioxidants
Cryoprotective Agents

ClinicalTrials.gov processed this record on July 22, 2014