Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy

This study has been completed.

Sponsor:

Information provided by:

Arcion Therapeutics Inc

ClinicalTrials.gov Identifier:

NCT00695565

First received: June 10, 2008

Last updated: January 22, 2010

Last verified: January 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	June 10, 2008
Last Updated Date	January 22, 2010
Start Date ^ICMJE	May 2008
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 10, 2008)	mean change from Baseline in NPRS score [ 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 NCT00695565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 10, 2008)	mean change from Baseline in NPRS score at each week [ Time Frame: weekly ] [ Designated as safety issue: No ] Percentage of subjects who experience at least 30% or at least 50% reduction in pain intensity from Baseline to each week of treatment [ Time Frame: weekly ] [ 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	Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Painful Diabetic Neuropathy
Intervention ^ICMJE	Drug: placebo TID x 12 weeks Drug: topical clonidine (ARC-4558) TID x 12 weeks
Study Arm (s)	Placebo Comparator: 1. Placebo Intervention: Drug: placebo Active Comparator: 2. ARC-4558 Intervention: Drug: topical clonidine (ARC-4558)
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	Completed
Estimated Enrollment ^ICMJE	170
Completion Date	December 2009
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: has Type 1 or Type 2 diabetes mellitus has a history of chronic pain attributable to a symmetrical stocking distribution neuropathy in the lower extremities for a duration of at least six months but less than or equal to five years prior to Screening Exclusion Criteria: has neuropathy secondary to non-diabetic causes has a significant neurological disorder or a condition that can cause symptoms that mimic peripheral neuropathy or might confound assessment of PDN has other chronic pain with intensity at or greater than the bilateral pain in the feet/toes is using an implanted medical device (eg, spinal cord stimulator, intrathecal pump, or peripheral nerve stimulator) for the treatment of pain is pregnant or lactating
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00695565
Other Study ID Numbers ^ICMJE	CLO-027
Has Data Monitoring Committee	Yes
Responsible Party	James N. Campbell, MD, Chief Executive Officer, Arcion Therapeutics Inc
Study Sponsor ^ICMJE	Arcion Therapeutics Inc
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Arcion Therapeutics Inc
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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