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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03113448 |
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Date of registration:
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09/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy
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Scientific title:
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0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy: A Randomized, Double- Blind, Crossover, Placebo-Controlled Trial |
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Date of first enrolment:
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January 19, 2017 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03113448 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Pasiri Sithinamsuwan |
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Address:
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Telephone:
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Email:
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Affiliation:
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Phramongkutklao College of Medicine |
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Name:
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Kongkiat Kulkantrakorn, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Thammasat University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. DM type 2 over 1 year
2. Clinical presentation of peripheral sensory such as burning pain
3. DN4 score from 4 points
4. Good consciousness to tell their score with informed consent agreement
5. No adding dosage of previous pain control medications at least 4 weeks
6. HbA1C 6.5-9.0%
Exclusion Criteria:
1. Improper application site of skin for topical drugs such as abrasion wound.
2. Allergic history of Capsaicin
3. No intention to join the study with any reasons
4. Other previous medications used that effect to peripheral neuropathy such as
Carboplatin, Cisplatin, Colchicine, Dapsone, Etoposide, Ethambutol, Indomethacin,
Isoniazid, Lithium, Metronidazole, Phenytoin, Pyridoxine, Statins, Stavudine (d4T) or
conditions worsening peripheral nerves following that poor nutrition, kidney failure,
chronic alcoholism, vitamin deficiency, Hypothyroidism
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Peripheral Diabetic Neuropathy
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Intervention(s)
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Drug: 0.075% Capsaicin Lotion
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Drug: placebo
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Primary Outcome(s)
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Visual analog scale (0-100 mm.)
[Time Frame: 20 week]
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Secondary Outcome(s)
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Short-form McGill Pain Questionnaire(SF-MPQ)
[Time Frame: 20 week]
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Neuropathic Pain Scale (NPS)
[Time Frame: 20 week]
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Secondary ID(s)
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TCTR20170407001
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MTU-EC-IM-5-195/59
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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