Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

NCT ID: NCT00993070

Last Updated: 2012-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-12-31

Brief Summary

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Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain, but there is no data in lower concentration. This is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic polyneuropathy.

Detailed Description

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Patient is randomized to receive either 0.025% topical capsaicin or vehicle control (placebo) for 8 weeks. After one week wash-out period, patients will be switched to the other group for 8 weeks.

Outcome will be assessed by visual analog scale, neuropathic pain scale, SF-MPQ, SF-36. Safety and tolerability will be recorded.

Conditions

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Diabetic Polyneuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Capsaicin

Group Type EXPERIMENTAL

Capsaicin

Intervention Type DRUG

0.025% topical capsaicin applied 4 times per day for 8 weeks

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

vehicle gel, applied 4 times per day for 8 weeks

Interventions

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Capsaicin

0.025% topical capsaicin applied 4 times per day for 8 weeks

Intervention Type DRUG

placebo

vehicle gel, applied 4 times per day for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Capsika gel

Eligibility Criteria

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Inclusion Criteria

* History of type 2 Diabetes mellitus
* Peripheral neuropathy
* Stabilized on pain medication for at least one month
* No previous invasive intervention for pain relief

Exclusion Criteria

* Local wound or skin abnormality in the applicable area
* Allergic to capsaicin
* Refuse to participate or give consent
* Has other significant disease or receive medication that may worsen neuropathy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bangkok Drug company

UNKNOWN

Sponsor Role collaborator

Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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Kongkiat Kulkantrakorn

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kongkiat Kulkantrakorn, MD

Role: PRINCIPAL_INVESTIGATOR

Thammasat University

Locations

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Thammasat University Hospital

Pathum Thani, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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MTU-I-1-45/52

Identifier Type: -

Identifier Source: org_study_id

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