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

June 10, 2008
January 22, 2010
May 2008
December 2009   (final data collection date for primary outcome measure)
mean change from Baseline in NPRS score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00695565 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy
Not Provided

The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Painful Diabetic Neuropathy
  • Drug: placebo
    TID x 12 weeks
  • Drug: topical clonidine (ARC-4558)
    TID x 12 weeks
  • Placebo Comparator: 1. Placebo
    Intervention: Drug: placebo
  • Active Comparator: 2. ARC-4558
    Intervention: Drug: topical clonidine (ARC-4558)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00695565
CLO-027
Yes
James N. Campbell, MD, Chief Executive Officer, Arcion Therapeutics Inc
Arcion Therapeutics Inc
Not Provided
Not Provided
Arcion Therapeutics Inc
January 2010

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