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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 (Responsible Party):
Arcion Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00695565
First received: June 10, 2008
Last updated: September 21, 2016
Last verified: September 2016

June 10, 2008
September 21, 2016
May 2008
December 2009   (final data collection date for primary outcome measure)
Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation [ Time Frame: Baseline (average of Days -7 to -1) and Week 12 (Average of Days 78 to 84) ] [ Designated as safety issue: No ]

Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS) through Day 84. Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated "no pain" and a score of 10 was "worst possible pain".

The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement (more pain relief).

mean change from Baseline in NPRS score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00695565 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation [ Time Frame: Baseline (average of Days -7 to -1) and Weeks 1 through 12 (weekly averages) ] [ Designated as safety issue: No ]
    Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated "no pain" and a score of 10 was "worst possible pain". A weekly average was calculated from the daily scores for each week. The change in pain is represented as the average weekly score minus Baseline, so greater negative numbers represent more improvement (more pain relief).
  • Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation [ Time Frame: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84) ] [ Designated as safety issue: No ]
    Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale. Subjects were asked to record the worst pain in their feet over the past 24 hours. A score of 0 indicated "no pain" and a score of 10 was "worst possible pain". The change in pain is represented as Week 12 minus Baseline, so greater negative numbers represent greater improvement (greater pain relief).
  • Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation [ Time Frame: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84) ] [ Designated as safety issue: No ]
    Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated "no pain" and a score of 10 was "worst possible pain".
  • Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation [ Time Frame: Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84) ] [ Designated as safety issue: No ]
    Pain in the feet was scored daily at bedtime by the subject on a 0-10 numeric pain rating scale (NPRS). Subjects were asked to record average pain in the feet over the past 24 hours. A score of 0 indicated "no pain" and a score of 10 was "worst possible pain".
  • Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The Brief Pain Inventory was completed by the subject at clinic visits. The Severity Scale (of 0 to 40) is a composite score, which is the sum of the individual ratings for worst pain, least pain, average pain, and current pain. Each individual question is rated on a scale of 0 to 10, where 0 indicates "No Pain" and 10 indicates "Pain as bad as you can imagine". The change in pain severity is represented as Week 12 minus Baseline, so greater negative numbers represent greater improvement (pain relief).
  • Change From Baseline in the Brief Pain Inventory Functional Interference Scale at Week 12; mLOCF Imputation [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

    The Brief Pain Inventory was completed by the subject at clinic visits. The Functional Interference Scale (of 0 to 70) is a composite score that measures the degree to which pain interferes with mood, walking, work, relationships, sleep, general activity, and enjoyment of life. The composite score is a sum of the seven individual question scores. Each individual question is rated in reference to pain over the past 24 hours on a scale of 0 to 10, where 0 indicates that pain "does not interfere" and 10 indicates that pain "completely interferes" with that function, so lower scores represent better outcomes on this scale.

    The change in functional interference is represented as Week 12 minus Baseline, so greater negative numbers represent more improvement.

  • Change From Baseline to Week 12 in Overall Quality of Sleep (Chronic Pain Sleep Inventory) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Subjects rated overall quality of sleep over the past week using a 100 mm Visual Analog Scale (VAS) where 100=Excellent and 0=Very Poor. This scale was completed during clinic visits. Change from Baseline is a positive value where quality of sleep improved.
  • Change From Baseline to Week 12 in the Depression Score of the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The HADS was completed at the Baseline and Week 12 clinic visits. The Depression Score component of the HADS includes 7 questions, each with 4 possible answer choices (rated 0 to 3). The composite score is created by adding the scores of the 7 individual questions. A score of 0 to 7 is Normal, 8-10 indicates Mild Depression, 11-14 indicates Moderate Depression, and 15-21 indicates Severe Depression. The change from Baseline is calculated as the Week 12 composite score minus the Baseline composite score.
  • Change From Baseline to Week 12 in the Anxiety Score of the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The HADS was completed at the Baseline and Week 12 clinic visits. The Anxiety Score component of the HADS includes 7 questions, each with 4 possible answer choices (rated 0 to 3). The composite score is created by adding the scores of the 7 individual questions. A score of 0 to 7 is Normal, 8-10 indicates Mild Anxiety, 11-14 indicates Moderate Anxiety, and 15-21 indicates Severe Anxiety. The change from Baseline is calculated as the Week 12 composite score minus the Baseline composite score.
  • Change From Baseline to Week 12 in the McGill Pain Questionnaire (Short Form) Total Score [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The McGill Pain Questionnaire asks subjects to rate 15 different kinds of pain, each on a scale of 0 to 3 (0=None, 1=Mild, 2=Moderate, 3=Severe). The total score is a sum of the individual ratings and has a range from 0 to 45, where higher numbers indicate more pain. The 15 types of pain assessed are throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting, tiring-exhausting, sickening, fearful, and punishing-cruel. This scale was completed at the Baseline and Week 12 clinic visits. The change from Baseline is calculated as the Week 12 total score minus the Baseline total score, so greater negative numbers indicate more improvement (pain relief).
  • Patient Global Impression of Change (PGIC) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    At Week 12 the subject was asked to rate their total improvement relative to Baseline, whether or not, in their judgement, it was due entirely to study drug treatment or not. Answer choices were: (+3) very much improved, (+2) much improved, (+1) minimally improved, (0) no change, (-1) minimally worse, (-2) much worse, (-3) very much worse.
  • Clinician Global Impression of Change (CGIC) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    At Week 12, the Investigator was asked to independently rate the subject's total improvement relative to Baseline, whether or not, in their judgement, it was due entirely to study drug treatment or not. Answer choices were: (+3) very much improved, (+2) much improved, (+1) minimally improved, (0) no change, (-1) minimally worse, (-2) much worse, (-3) very much worse.
  • Change in Blood Pressure From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: Yes ]
    Systolic and Diastolic Blood Pressure were measured at clinic visits. This outcome assesses the change in blood pressure from Baseline to Week 12 of treatment.
  • 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 ]
Not Provided
Not Provided
 
Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy
A Multicenter, Randomized, Double-Blind, Parallel-Group Study Comparing the Efficacy and Safety of Clonidine Topical Gel, 0.1% With Placebo in the Management of Pain Associated With Painful Diabetic Neuropathy
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 Gel
    TID x 12 weeks
  • Drug: Clonidine Topical Gel (ARC-4558)
    TID x 12 weeks
  • Placebo Comparator: Placebo Gel
    Placebo Gel is vehicle without clonidine
    Intervention: Drug: Placebo Gel
  • Active Comparator: Clonidine Topical Gel (ARC-4558)
    Clonidine Topical Gel contains 0.1% clonidine hydrochloride
    Intervention: Drug: Clonidine Topical Gel (ARC-4558)
Campbell CM, Kipnes MS, Stouch BC, Brady KL, Kelly M, Schmidt WK, Petersen KL, Rowbotham MC, Campbell JN. Randomized control trial of topical clonidine for treatment of painful diabetic neuropathy. Pain. 2012 Sep;153(9):1815-23. doi: 10.1016/j.pain.2012.04.014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
February 2010
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 to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00695565
CLO-027
Yes
Undecided
Not Provided
Arcion Therapeutics Inc
Arcion Therapeutics Inc
Not Provided
Study Chair: James N Campbell, M.D. Arcion Therapeutics Inc
Arcion Therapeutics Inc
September 2016

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