A Study Evaluating Nexagon™ in the Treatment of Skin Wounds.
This study has been completed.
Sponsor:
CoDa Therapeutics Inc.
Information provided by:
CoDa Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00736593
First received: August 14, 2008
Last updated: April 23, 2009
Last verified: April 2009
| Tracking Information | |||||
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| First Received Date ICMJE | August 14, 2008 | ||||
| Last Updated Date | April 23, 2009 | ||||
| Start Date ICMJE | September 2008 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Assessed by the incidence of adverse events from the time of application of the investigational product [ Time Frame: Until the end of the study. ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00736593 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study Evaluating Nexagon™ in the Treatment of Skin Wounds. | ||||
| Official Title ICMJE | A Phase 1 Randomized, Prospective, Within-Subject, Double-Blind, Vehicle-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Clinical Effect of Nexagon™ in Full-Thickness Punch Wounds | ||||
| Brief Summary | Nexagon™ is a novel compound that promotes wound healing by temporarily disrupting cellular communication at the wound site, thereby promoting accelerated healing, reducing inflammation and pain. This randomized double-blind study will assess the safety, tolerability and clinical effect of Nexagon™ when applied to skin wounds created by punch biopsy in healthy volunteers. 43 healthy, fair-skinned males and females between ages 18-40 will be enrolled. Subjects will be reviewed again at 3 months and 9 months for follow-up safety assessments and wound appearance evaluation. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Wound Healing | ||||
| Intervention ICMJE | Drug: Nexagon™ or Nexagon™ vehicle | ||||
| Study Arm (s) | Experimental: 1
Intervention: Drug: Nexagon™ or Nexagon™ vehicle |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 43 | ||||
| Completion Date | April 2009 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | New Zealand | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00736593 | ||||
| Other Study ID Numbers ICMJE | NEX-SKI-001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Alexis White, CoDaTherapeutics | ||||
| Study Sponsor ICMJE | CoDa Therapeutics Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | CoDa Therapeutics Inc. | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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