Effects of Pennsaid on Clinical Neuropathic Pain

NCT01508676 | Completed Results

• 1 other identifier: 2011p000897
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuralgia; Postherpetic Neuralgia; Reflex Sympathetic Dystrophy; Complex Regional Pain Syndrome (CRPS)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Clinical Neuropathic Pain Features- Burning After Treatment

  2 weeks

• Clinical Neuropathic Pain Features- Constant Pain and Hypersensitivity After Treatment

  2 weeks

Study Arms (2)

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.

Drug: Pennsaid

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.

Drug: Placebo (2.3% DMSO solution)

Interventions

Pennsaid DRUG

Also known as: Pennsaid topical 1.5% diclofenac, a non-steroid anti-inflammatory drug

Pennsaid Phase I

Placebo (2.3% DMSO solution) DRUG

Also known as: Placebo (2.3% DMSO solution; 20-40 drops; 2-4 times daily).

Placebo Phase I

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject will be between 18 and 80 years of age.
• Subject has not been on Pennsaid or other topical non-steroid anti-inflammatory drugs for at least one month.
• 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.
• Subject has a VAS pain score of 4 or above at the beginning of the study.
• 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.
• Female subjects of childbearing age must have a negative urine pregnancy test at the initial visit.

You may not qualify if:

• 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.)
• Subject has pending litigation related to the neuropathic pain condition.
• Subject has active skin lesion or open wound at the site of Pennsaid application (e.g., active shingles with skin lesions).
• Subject is pregnant or lactating.
• Subject has scar tissue or sensory deficit at the site of QST.
• Subject is allergic to diclofenac or has cross-sensitivity to other non-steroid anti-inflammatory drugs.
• Subject has a positive urine (illicit) drug test.
• Subjects who experience asthma, urticaria or an allergic type reaction when taking aspirin or NSAIDs.
• Subjects undergoing coronary artery bypass surgery.
• Subject with a known history of cardiovascular disease, ulcer, gastrointestinal bleed or impaired renal function.
• Subjects currently using NSAIDS.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH Center for Translational Pain Research

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neuralgia; Neuralgia, Postherpetic; Reflex Sympathetic Dystrophy; Complex Regional Pain Syndromes

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Jianren Mao
• Organization: Massachusetts General Hospital

mghpainresearch@partners.org

6177246102

Study Officials

• Jianren Mao, M.D., Ph.D.

  DACCPM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair Research

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 12, 2012
• Study Start: November 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: January 1, 2016
• Last Updated: February 6, 2017
• Results First Posted: February 6, 2017

Record last verified: 2016-12

Locations

US (1)