- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02484170
Mannitol Cream for Post Herpetic Neuralgia (MannitolPHN)
Mannitol Cream in the Treatment of Post-herpeticNeuralgia;a Randomized Placebo-Controlled Crossover Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
British Columbia
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North Vancouver, British Columbia, Canada, V7M 2K2
- Dr. Helene Bertrand Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- - Suffering from post-herpetic neuralgia on the trunk or the extremities for at least three months.
- - Maximum daily pain score greater than or equal to 5/10.
- - Having failed to improve with at least one neuropathic pain medication.
4- Able and willing to fill a fluid survey NRS pain scale and a medication intake questionnaire daily, preferably online but on paper, if unable, for the first 24 days of the study, then once a month for three months..
5 - Preferably have access to someone who can apply cream to their back if they have pain in the back and cannot reach the area.
6 - If that is not possible, ability to apply the cream to their own back, using an applicator which will be supplied.
Exclusion Criteria:
- Allergies to any of the ingredients of the cream
- Open lesions or abrasions on the skin where the cream will be applied
- Using corticosteroids
- Unwilling to stop using other topical products (creams or patches) for the treatment of post-herpetic neuralgia
- Pregnant, breast-feeding or not using birth control
Suffering from severe chronic pain from a cause other than post-herpetic neuralgia
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: mannitol in vehicle cream /vehicle cream
one week on the mannitol cream (mannitol 30% in vehicle cream), a 3 day washout period, and one week on the placebo cream (vehicle cream alone).
To be applied over the painful area as needed for pain.
Usual frequency is 2 to 3 times daily.
|
Apply to area of postherpetic neuralgia pain as needed for pain control.
Usual frequency is 2 to 3 times per day.For crossover study, will be applied for 7 days.
For observational study, will be applied up to 3 months
Other Names:
Apply to area of postherpetic neuralgia pain as needed for pain control.Usual frequency is unknown.
For crossover study, will be applied for 7 days.
Will not be used after crossover study
Other Names:
|
Active Comparator: vehicle cream /mannitol in vehicle cream
one week on the placebo cream (vehicle cream alone), a 3 day washout period, and one week on the mannitol cream (mannitol 30% in vehicle cream).To be applied over the painful area as needed for pain.
Usual frequency is unknown.
|
Apply to area of postherpetic neuralgia pain as needed for pain control.
Usual frequency is 2 to 3 times per day.For crossover study, will be applied for 7 days.
For observational study, will be applied up to 3 months
Other Names:
Apply to area of postherpetic neuralgia pain as needed for pain control.Usual frequency is unknown.
For crossover study, will be applied for 7 days.
Will not be used after crossover study
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in worst NRS (Numerical Rating Scale) pain score
Time Frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
|
In the last 24 hours, how bad was your pain at its worst?
No pain 0 1 2 3 4 5 6 7 8 9 10 Worst pain imaginable
|
Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
|
Change in average NRS (Numerical Rating Scale) pain score
Time Frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
|
In the last 24 hours, how bad was your pain on average?
No pain 0 1 2 3 4 5 6 7 8 9 10 Worst pain imaginable
|
Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain medication intake
Time Frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3,months
|
Number of pills taken for pain in one day.
Will decrease as the pain intensity decreases.
Write the number of tablets that you took: 1. Tylenol/acetaminophen______, 2. Anti-inflammatory medication like Advil/ibuprofen, naproxen, diclofenac, Voltaren, Aleve______, 3. Tylenol or ASA (acetylsalicylic acid) plus narcotic like Tylenol 3, or 292 or Tramacet (acetaminophen/tramadol) ______, 4. Narcotic like morphine, hydromorphone/dilaudid, fentanyl, Demerol, tramadol______, 5. Cannabis, marijuana, or pot______, The total in each category will be added to calculate the total number of tablets taken in 24 hours.
|
Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3,months
|
Change in Alcohol intake
Time Frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
|
Number of alcoholic drinks in one day.
May decrease as the pain intensity decreases.
Write down the total number of alcoholic drinks you had in the last 24 hours:how many glasses of wine ______ glasses of hard liquor______ bottles of beer______.
The total number of glasses will be recorded.
|
Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
|
Change in questions from the brief pain inventory score
Time Frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
|
The total from the following questions will be recorded to measure how much their pain is interfering with their lives: Circle one number. In the last 24 hours, how much has your pain interfered with your: General activity:, Mood: Walking ability: Normal work: (includes both work outside the home and housework) Relations with other people: Sleep: Enjoyment of life: Each of these will be scored as follows: does not interfere 0 1 2 3 4 5 6 7 8 9 10 completely interferes. The scores added up. This sum should decrease as the pain decreases. |
Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
|
Change in PHQ-9 (Personal health questionnaire, 9 questions) Score
Time Frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
|
Patients will fill the PHQ - 9 score.
http://phqscreeners.com/pdfs/02_PHQ-9/English.pdf
The sum of the answers from this questionnaire, which is used to measure the degree of depression, may decrease as the pain intensity decreases.
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Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
|
Change in Method of cream application
Time Frame: when each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
|
Patients will describe whether they use cling wrap (4), gentle applicator (3) or rubbing in gently (2) or vigourous rubbing (1)
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when each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
|
Change in effect and side effects of the cream
Time Frame: Daily for the 14 days, of the crossover study, then at 1,2 and 3 months
|
How many times did you apply the cream today?_______
Circle one number.
How bad was your pain?.. Before you applied the cream?
NRS 0-10 1hour after you applied the cream?
NRS 0-10 Did the cream relieve your pain?
No □ if Yes □ in how many minutes?____
For how many hours was your pain relieved?____
Did you experience a side effect from the cream?
No □ if Yes □ What was it?_________________
Any comments?_______________________
|
Daily for the 14 days, of the crossover study, then at 1,2 and 3 months
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Satisfaction from cream use
Time Frame: Three months after use of mannitol cream was started.
|
How satisfied were you with the use of this cream?
Not at all satisfied 0 1 2 3 4 5 6 7 8 9 10 extremely satisfied
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Three months after use of mannitol cream was started.
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Change in pain score from mannitol cream use to mannitol and menthol cream use
Time Frame: 1st measurement Three months after use of mannitol cream was started 2nd measurement one month after mannitol and menthol cream started
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Maximum pain score after 3 months of mannitol cream use compared to maximum pain score after one month of mannitol and menthol cream use
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1st measurement Three months after use of mannitol cream was started 2nd measurement one month after mannitol and menthol cream started
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Helene Bertrand, MD, CM, CCFP, University of British Columbia, Department of family practice
Publications and helpful links
General Publications
- Bertrand H, Kyriazis M, Reeves KD, Lyftogt J, Rabago D. Topical Mannitol Reduces Capsaicin-Induced Pain: Results of a Pilot-Level, Double-Blind, Randomized Controlled Trial. PM R. 2015 Nov;7(11):1111-1117. doi: 10.1016/j.pmrj.2015.05.002. Epub 2015 May 12.
- Gilron I, Baron R, Jensen T. Neuropathic pain: principles of diagnosis and treatment. Mayo Clin Proc. 2015 Apr;90(4):532-45. doi: 10.1016/j.mayocp.2015.01.018.
- Shannon HJ, Anderson J, Damle JS. Evidence for interventional procedures as an adjunct therapy in the treatment of shingles pain. Adv Skin Wound Care. 2012 Jun;25(6):276-84; quiz 285-6. doi: 10.1097/01.ASW.0000415345.22307.f3.
- Szolcsanyi J, Sandor Z. Multisteric TRPV1 nocisensor: a target for analgesics. Trends Pharmacol Sci. 2012 Dec;33(12):646-55. doi: 10.1016/j.tips.2012.09.002. Epub 2012 Oct 12.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H15-01260
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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