Diabetic Neuropathy Topical Treatment
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Irmandade da Santa Casa de Misericordia de Sao Paulo.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Irmandade da Santa Casa de Misericordia de Sao Paulo
Information provided by:
Irmandade da Santa Casa de Misericordia de Sao Paulo
ClinicalTrials.gov Identifier:
NCT00661063
First received: April 15, 2008
Last updated: April 17, 2008
Last verified: April 2008
| 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 | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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 | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) 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:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00661063 | ||||
| Other Study ID Numbers ICMJE | 042/2007 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Judymara Lauzi Gozzani PhD, ISCMSP | ||||
| Study Sponsor ICMJE | Irmandade da Santa Casa de Misericordia de Sao Paulo | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Irmandade da Santa Casa de Misericordia de Sao Paulo | ||||
| Verification Date | April 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||