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Trial record 11 of 188 for:    menthol

Topical Menthol +/- Mannitol for Painful Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT02728687
Recruitment Status : Unknown
Verified May 2017 by Helene Bertrand, University of British Columbia.
Recruitment status was:  Recruiting
First Posted : April 5, 2016
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Helene Bertrand, University of British Columbia

Brief Summary:
Treatments for painful diabetic peripheral neuropathy (PDPN) are not very effective and have multiple side effects. To find out if a menthol cream alone or with added mannitol treats PDPN effectively, 90 participants with PDPN, after one month of observation, will receive randomly assigned menthol cream or the same cream with mannitol added for 3 months with a crossover for 3 additional months. At time 0, 1,4 and 7 months their BPI pain severity and interference scores, DN4 scores, cream % effectiveness and side effects will be compared.

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Drug: Mannitol Drug: Menthol Phase 1 Phase 2

Detailed Description:

Purpose: to find out if a menthol cream containing mannitol is more effective than the same cream without mannitol in relieving painful diabetic peripheral neuropathy (PDPN). The test cream which will, at a later date, be marketed as QR cream contains Water, Mannitol, Propylene glycol, Isopropyl palmitate. Caprylic capric triglyceride, Ceteareth 20, Cetearyl alcohol, Glyceryl stearate, Polyethylene glycol 100 Stearate, Dimethicone, Octyldodecanol, Menthol, Lecithin, Ethylhexyl glycerin, Phenoxyethanol. The control cream contains the same ingredients minus the mannitol.

Hypothesis: a menthol cream containing mannitol is more effective at relieving the pain, the physical limitations and the emotional distress caused by PDPN than the same cream without mannitol.

Justification: PDPN is common and can be disabling because of the intensity of the pain it can cause. Less than 50% of those suffering from this condition get adequate pain relief from their current medications. The oral medications, anticonvulsants, antidepressants, NSAIDS, marijuana derivatives and narcotics have numerous side effects and are potentially addictive. Topical local anaesthetics have short-lived effect over only a small area and topical capsaicin often causes burning on application and prolonged use destroys the affected nerves. A previous study has demonstrated mannitol's effectiveness in down regulating the capsaicin receptor which is believed to cause the burning sensation of PDPN. A cream containing mannitol has few side effects, and, if effective, may decrease the need for other, more dangerous medications.

Objectives: to show that a menthol cream containing mannitol is more effective, over a period of 28 weeks, than the same cream without mannitol at relieving the pain, the physical limitations and the emotional distress caused by PDPN.

Research Design: this is a randomized, double-blind, placebo-controlled crossover trial involving 3 visits.

Participants who are taking medications or insulin to treat diabetes will have on/off vibration test on the hallux of each foot. If at least 5 of their 8 vibration tests are erroneous or "I don't know", their score on the DN4 questionnaire is >4/10 they will be enrolled.

After 1 month's observation period, 90 participants will be given either a menthol cream with mannitol or the same cream without mannitol to apply to their feet for 3 months, following which the creams will be crossed over for an additional 3 months. Which cream is to be applied in the first 3 months will be chosen at random. Participants and clinicians will be blinded as to cream assignment for the duration of the study. Participants will be instructed to rub the cream on their feet and the tender nerves supplying their feet, 2 to 4 times daily, as needed for pain relief.

At 0,1,4 and 7 month, their BPI pain severity and interference scores, DN4 scores, cream % effectiveness and side effects will be recorded. At 4 and 7 months, they will be compared.

Statistical Analysis: primary endpoint, BPI pain interference scores (how much pain interferes with function and relationships) . t-tests will compare the difference between the maximum daily pain interference score for the menthol cream as compared with the mannitol and menthol cream at 4 and 7 months. Secondary endpoints: BPI pain severity score and DN4 score (how many symptoms of peripheral neuropathy are registered), % cream effectiveness, incidence of side effects.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized Crossover Study of Efficacy and Safety of Topical Menthol, With and Without Mannitol, in the Treatment of Painful Diabetic Peripheral Neuropathy
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mannitol and menthol cream
Mannitol and menthol cream (Water, Mannitol, Propylene glycol, Isopropyl palmitate. Caprylic capric triglyceride, Ceteareth 20, Cetearyl alcohol, Glyceryl stearate, Polyethylene glycol 100 Stearate, Dimethicone, Octyldodecanol, Menthol, Lecithin, Ethylhexyl glycerin, Phenoxyethanol) applied as needed, up to 4 times daily for one month, to the feet of a person suffering from painful diabetic peripheral neuropathy. During the other month, the menthol cream will be applied to the participant's feet. Whether the mannitol and menthol cream will be given in the first or the second month will be chosen at random. At the end of the 2 months, if the participant chooses this cream, they will be given 3 months' supply of the cream to apply as needed to both feet.
Drug: Mannitol
Apply cream as needed up to 4 times daily to the painful foot and leg
Other Name: QR cream

Drug: Menthol
Apply cream as needed up to 4 times daily to the painful foot and leg

Active Comparator: Menthol cream
Cream containing menthol (Water, Propylene glycol, Isopropyl palmitate. Caprylic capric triglyceride, Ceteareth 20, Cetearyl alcohol, Glyceryl stearate, Polyethylene glycol 100 Stearate, Dimethicone, Octyldodecanol, Menthol, Lecithin, Ethylhexyl glycerin, Phenoxyethanol) applied as needed, up to 4 times daily for one month, to the feet of a person suffering from painful diabetic peripheral neuropathy. During the other month, the mannitol and menthol cream will applied to the participant's feet. Whether the menthol cream will be given in the first or the second month will be chosen at random. At the end of the 2 months, if the participant chooses this cream, they will be given 3 months' supply of the cream to apply as needed to both feet.
Drug: Menthol
Apply cream as needed up to 4 times daily to the painful foot and leg




Primary Outcome Measures :
  1. BPI pain interference improvement 3 months [ Time Frame: 3 month ]
    Compares the change in BPI pain interference score after 3 months of cream use for menthol and mannitol cream and menthol cream alone.


Secondary Outcome Measures :
  1. Maximum BPI pain severity improvement 3 months [ Time Frame: 3 months ]
    Compares the change in maximum BPI pain severity score after 3 months of cream use for menthol and mannitol cream and menthol cream alone.

  2. NH4 improvement 3 month [ Time Frame: 3 months ]
    Compares the change in NH4 score after 3 months of cream use for menthol and mannitol cream and menthol cream alone.

  3. % improvement from cream use [ Time Frame: 3 months ]
    Compares the % improvement from cream use after 3 months of cream use for menthol and mannitol cream and menthol cream alone.

  4. Satisfaction score [ Time Frame: 3 months ]
    Compares the Satisfaction score from cream use after 3 months of cream use for menthol and mannitol cream and menthol cream alone.

  5. incidence of side effects [ Time Frame: 3 months ]
    Compares the incidence of side effects from cream use after 3 months of cream use for menthol and mannitol cream and menthol cream alone.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • 19 years of age or older
  • Are currently being treated for diabetes with medications or insulin
  • Suffering from painful diabetic peripheral neuropathy affecting their feet for at least three months.
  • Maximum daily pain or discomfort score in each foot greater than or equal to 5/10.
  • Score on the DN4 questionnaire at least 4/10
  • At least 5 incorrect or I don't know responses to 8 on/off vibration tests
  • Able and willing to attend Dr. Helene Bertrand's office three times.

Exclusion Criteria:

  • • Known Allergies to any of the ingredients of the cream
  • Open lesions diabetic foot ulcers or abrasions on the skin where the cream will be applied
  • Unwilling to stop using other topical products (creams or patches) for the treatment of their neuropathic pain at least 14 days before joining this study.
  • Pain in each foot which varies by more than 2/10 from day-to-day
  • Pregnant (a urine pregnancy test will be done on women younger than 50 at their first visit )
  • breast-feeding,
  • Women of reproductive age and not using the following methods of contraception:

    1. Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (DepoProvera, Lunelle), or hormone implant (Norplant System)
    2. Double-barrier method
    3. Non-hormonal intrauterine devices
    4. Vasectomy of partner
  • Limited standing or walking from any cause (back, knees, feet, etc) other than diabetic neuropathic pain.
  • Giving a history or exhibiting clinical signs of other causes of neuropathic pain such as spinal claudication, severe back pain on standing or walking, or a history of having received chemotherapy.
  • Pain extending above the ankles.
  • Those with ischemic peripheral vascular disease
  • Those receiving acupuncture or using a TENS machine Those undergoing hydrotherapy
  • Those who are unable to understand English, French, or Spanish and can not attend Dr. Bertrand's office with someone who will translate for them.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728687


Contacts
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Contact: Helene Bertrand, MD, CM, CCFP 604-985-5381 dr.hertrand@Gmail.com
Contact: Lori Molleken, MOA 604 985 5381 Lorialoha@Hotmail.com

Locations
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Canada, British Columbia
Dr. Helene Bertrand Inc., 220-1940 Lonsdale Ave. Recruiting
North Vancouver, British Columbia, Canada, V7M 2K2
Contact: Lori Molleken's, MOA    604-985-5381    heleneb@mail.ubc.ca   
Principal Investigator: Helene Bertrand, MD, CM, CCFP         
Okanagan Interventional Pain Clinic, Not yet recruiting
Suite 303 - 570 Raymer Avenue, Kelowna, British Columbia, Canada, V1Y 4Z5
Contact: François Louw, MBCHB    250-860-9754    whatsupdok@shaw.ca   
Sponsors and Collaborators
University of British Columbia

Publications:
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Responsible Party: Helene Bertrand, MD, CCFP, Clinical instructor, Department of family practice University of British Columbia, University of British Columbia
ClinicalTrials.gov Identifier: NCT02728687     History of Changes
Other Study ID Numbers: M for PDPN
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Age, sex, pain medications used, brief pain inventory pain interference and pain severity scores (BPI), DN4 (neuropathy questionnaire), % effectiveness and side effects of cream.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Helene Bertrand, University of British Columbia:
peripheral neuropathy
Diabetes
Pain

Additional relevant MeSH terms:
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Menthol
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Antipruritics
Dermatologic Agents