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NCT Number: NCT00993070

Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy

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.

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Key information

Conditions

Diabetic Polyneuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Thammasat University Hospital

Pathum Thani, 12120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capsaicin

Drug

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

Other names: Capsika gel

Placebo

Drug

vehicle gel, applied 4 times per day for 8 weeks

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

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

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Collaborators

  • Bangkok Drug company

Registry information

Official study title

A Randomized, Crossover, Double Blinded, Placebo Controlled Trial of Topical Capsaicin in Treatment of Painful Diabetic Neuropathy

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 9, 2009
Registry last updated
May 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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