Diabetic Neuropathy Topical Treatment - Tabular View

Tracking Information

First Received Date ^ICMJE

April 15, 2008

Last Updated Date

April 17, 2008

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

pain evaluation by visual analogue scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00661063 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

pain evaluation by amount of rescue medication required [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Diabetic Neuropathy Topical Treatment

Official Title ^ICMJE

Diabetic Neuropathic Pain Topical Treatment- Comparative Study

Brief Summary

Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetic Neuropathy
Pain

Intervention ^ICMJE

Drug: ketamine
Drug: vehicle gel
Drug: ketamine + clonidine
Drug: clonidine gel 1%

Study Arms / Comparison Groups

Experimental: drug - ketamine 1% gel
Placebo Comparator: vehicle gel
Experimental: association of ketamine and clonidine gel
Experimental: clonidine gel

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

June 2009

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diabetes Mellitus type I or II
Mono or polyneuropathy
Treatment with Tricyclic Antidepressant, Carbamazepine during 3 weeks at least
Preserved cognition

Exclusion Criteria:

Ulcerative or infection or vesicle lesion in pain site
Pregnancy
Breast feeding

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Judymara L Gozzani, investigator

55-11-3884-0865

gozzani@osite.com.br

Location Countries ^ICMJE

Brazil

Administrative Information

NCT ID ^ICMJE

NCT00661063

Responsible Party

Judymara Lauzi Gozzani PhD, ISCMSP

Study ID Numbers ^ICMJE

042/2007

Study Sponsor ^ICMJE

Irmandade da Santa Casa de Misericordia de Sao Paul

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Judymara L Gozzani, Investigator

Santa Casa de São Paulo

Information Provided By

Irmandade da Santa Casa de Misericordia de Sao Paul

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP