NCT01125215

Brief Summary

The objectives of this study are to determine efficacy and safety of 0.75% topical capsaicin nanoparticle preparation versus placebo in patient with painful diabetic neuropathy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2009

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

4.1 years

First QC Date

May 15, 2010

Last Update Submit

April 10, 2013

Conditions

Painful Diabetic Neuropathy

Keywords

Painful diabetic neuropathyCapsaicinNanoparticleQuantitative Sensory Testing

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matched gel base of capsaicin nanoparticle

Drug: Placebo

Capsaicin

EXPERIMENTAL

0.075% capsaicin nanoparticle gel

Drug: 0.75% capsaicin nanoparticle cream

Interventions

0.75% capsaicin nanoparticle creamDRUG

0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks

Capsaicin
PlaceboDRUG

Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks

Placebo

Eligibility Criteria

Age18 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 any 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 (2)

Ramathibodi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

Thammasat University Hospital

Pathum Thani, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Chuthamanee Suthisisang, PhD.

    Faculty of Pharmacy,Mahidol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr.

Study Record Dates

First Submitted

May 15, 2010

First Posted

May 18, 2010

Study Start

September 1, 2009

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations

TH(2)