NCT00993070

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 9, 2012

Status Verified

May 1, 2012

Enrollment Period

2.2 years

First QC Date

October 7, 2009

Last Update Submit

May 8, 2012

Conditions

Diabetic Polyneuropathy

Keywords

capsaicinplacebotrialdiabetic polyneuropathyneuropathic pain

Outcome Measures

Primary Outcomes (1)

  • Pain relief from pain score reduction, using visual analog scale (VAS)

    8 weeks

Secondary Outcomes (1)

  • Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC)

    8 weeks

Study Arms (2)

Capsaicin

EXPERIMENTAL
Drug: Capsaicin

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

CapsaicinDRUG

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

Also known as: Capsika gel
Capsaicin
placeboDRUG

vehicle gel, applied 4 times per day for 8 weeks

placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thammasat University Hospital

Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Diabetic NeuropathiesNeuralgia

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated AlkamidesAmidesOrganic ChemicalsAlkenesHydrocarbons, AcyclicHydrocarbonsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Study Officials

  • Kongkiat Kulkantrakorn, MD

    Thammasat University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 9, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 9, 2012

Record last verified: 2012-05

Locations

TH(1)