NeuralgiaNCT01508676
Effects of Pennsaid on Clinical Neuropathic Pain
A study testing Pennsaid in people with Neuralgia and Postherpetic Neuralgia, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuralgia, Postherpetic Neuralgia, Reflex Sympathetic Dystrophy
- What is being tested?
- Pennsaid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Center for Translational Pain Research
Boston, Massachusetts, 02114
About this study
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.
Read the 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).
- Conditions
- Neuralgia, Postherpetic Neuralgia, Reflex Sympathetic Dystrophy, Complex Regional Pain Syndrome (CRPS)
- Being tested
- Pennsaid, Placebo (2.3% DMSO solution)
- Keywords
- neuropathic pain, postherpetic neuralgia, complex regional pain syndrome, reflex sympathetic dystrophy
- Medical subject headings
- Neuralgia, Neuralgia, Postherpetic, Reflex Sympathetic Dystrophy, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PennsaidDrug
Also called Pennsaid topical 1.5% diclofenac, a non-steroid anti-inflammatory drug
Placebo (2.3% DMSO solution)Drug
Also called Placebo (2.3% DMSO solution; 20-40 drops; 2-4 times daily).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo (2.3% DMSO solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks.
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionMar 2013
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianren Mao, MD, PhD, Massachusetts General Hospital
- Investigators
- Jianren Mao, M.D., Ph.D., Principal investigator, DACCPM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508676
- Sponsor's protocol ID
- 2011p000897
- Status last verified
- Dec 2016
- First submitted
- 4 Jan 2012
- Last updated
- 6 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pennsaid on Clinical Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01508676
- Acronym / sponsor ID
- 2011p000897
- Conditions
- Neuralgia, Postherpetic Neuralgia, Reflex Sympathetic Dystrophy, Complex Regional Pain Syndrome (CRPS)
- Keywords
- neuropathic pain, postherpetic neuralgia, complex regional pain syndrome, reflex sympathetic dystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Posted 6 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pennsaid Phase I | Active comparator | Drug: PennsaidPennsaid (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 | Drug: Placebo (2.3% DMSO solution)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PennsaidAlso: Pennsaid topical 1.5% diclofenac, a non-steroid anti-inflammatory drug | Drug | Pennsaid Phase I |
| Placebo (2.3% DMSO solution)Also: Placebo (2.3% DMSO solution; 20-40 drops; 2-4 times daily). | Drug | Placebo Phase I |
Primary outcome
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 secondary outcomes
Clinical Neuropathic Pain Features- Burning After Treatment
Time frame: 2 weeks
Clinical Neuropathic Pain Features- Constant Pain and Hypersensitivity After Treatment
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianren Mao, M.D., Ph.D. principal investigator
DACCPM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pennsaid in people with Neuralgia and Postherpetic Neuralgia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS After Treatment (time frame: 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.