Capsaicin Nanoparticle in Patient With Painful Diabetic N... | NCT01125215

Studies
Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

NCT01125215

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Apr 11, 2013Estimated

Enrollment

60Estimated

Phase

Phase 2Phase 3

Conditions

Painful Diabetic Neuropathy

Interventions

0.75% capsaicin nanoparticle cream
Placebo

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Oct 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

May 15, 2010

First Submission Date that Met QC Criteria

May 17, 2010

First Posted Date

May 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2013

Last Update Posted Date

Apr 11, 2013Estimated

Name	Class
Thailand Research Fund	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain. Because of high concentration, conventional capsaicin topical preparation causing burning sensation and required several time of applications per day.

The nanoparticle of capsaicin topical preparation was developed with expectation of remaining efficacy, minimizing burning sensation and improving convenience of use.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
0.75% capsaicin nanoparticle cream	Drug	0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks	Capsaicin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain relief from pain score reduction, using visual analog scale (VAS)		12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chuthamanee Suthisisang, PhD.	Faculty of Pharmacy,Mahidol University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ramathibodi Hospital		Bangkok	Bangkok	10400	Thailand
Thammasat University Hospital

Type	Date	Date Unknown
Release	Mar 21, 2017
Reset	Apr 28, 2017

Submission Tracking

Estimated Results First Submitted Date

Mar 21, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 21, 2017			Apr 28, 2017

Condition Browse Module

MeSH Terms

ID	Term
D003929	Diabetic Neuropathies

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications

Browse Leaves

Not provided

Browse Branches

Not provided