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

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ClinicalTrials.gov Identifier: NCT00695565
Recruitment Status : Completed
First Posted : June 12, 2008
Results First Posted : November 8, 2016
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Arcion Therapeutics Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Painful Diabetic Neuropathy
Interventions Drug: Placebo Gel
Drug: Clonidine Topical Gel (ARC-4558)
Enrollment 180
Recruitment Details Subjects were recruited from May 2008 until September 2009. All study sites were medical clinics.
Pre-assignment Details

Subjects were required to meet all eligibility criteria at both the Screening and Baseline visits. If a subject met the Screening criteria but not the Baseline criteria, the subject was not eligible for enrollment.

Two subjects were randomized but were not treated because they were found ineligible. They are not counted in the 180 enrolled.

Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description Placebo Gel is vehicle without clonidine Clonidine Topical Gel contains 0.1% clonidine hydrochloride
Period Title: Overall Study
Started 90 90
Completed 77 81
Not Completed 13 9
Reason Not Completed
Lost to Follow-up             4             4
Adverse Event             3             1
Protocol Violation             3             1
Withdrawal by Subject             1             1
Lack of Efficacy             1             1
Subject did not follow instructions             1             1
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558) Total
Hide Arm/Group Description Placebo Gel is vehicle without clonidine Clonidine Topical Gel contains 0.1% clonidine hydrochloride Total of all reporting groups
Overall Number of Baseline Participants 90 90 180
Hide Baseline Analysis Population Description
ITT (Intent-to-Treat)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 90 participants 180 participants
57.6  (9.5) 59.4  (9.9) 58.5  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 90 participants 180 participants
Female
48
  53.3%
46
  51.1%
94
  52.2%
Male
42
  46.7%
44
  48.9%
86
  47.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 90 participants 90 participants 180 participants
90 90 180
1.Primary Outcome
Title Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation
Hide Description

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).

Time Frame Baseline (average of Days -7 to -1) and Week 12 (Average of Days 78 to 84)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One treated subject had no recorded scores and could not be included. Imputation was mLOCF (modified Last Observation Carried Forward): LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication (in which case Baseline Observation Carried Forward (BOCF) was used).
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description:
Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Overall Number of Participants Analyzed 90 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
All subjects -1.9  (1.9) -2.4  (2.1)
Capsaicin response ≥ 2 -1.5  (1.8) -2.7  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Gel, Clonidine Topical Gel (ARC-4558)
Comments This analysis does not take into account the subjects' screening capsaicin response (measure of nociceptor function).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.168
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Gel, Clonidine Topical Gel (ARC-4558)
Comments

Each subject was screened for responsiveness of nociceptors in the skin to a capsaicin stimulus (rated on 0-10 pain scale; 0=no pain and 10=worst possible pain). The interaction term composed of treatment assignment and capsaicin threshold was examined at the prespecified alpha level of 0.1.

This analysis includes subjects with a capsaicin rating of ≥ 2. Thirty (30) subjects in the Placebo group and 33 subjects in the active Clonidine Topical Gel (ARC-4558) group had capsaicin scores ≥ 2.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation
Hide Description 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).
Time Frame Baseline (average of Days -7 to -1) and Weeks 1 through 12 (weekly averages)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation)
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description:
Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Overall Number of Participants Analyzed 90 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 -0.6  (1.01) -0.7  (1.34)
Week 2 -1.0  (1.30) -1.0  (1.45)
Week 3 -1.2  (1.47) -1.5  (1.58)
Week 4 -1.5  (1.63) -1.6  (1.71)
Week 5 -1.7  (1.77) -1.7  (1.65)
Week 6 -1.8  (1.84) -1.8  (1.74)
Week 7 -1.8  (1.83) -2.1  (1.86)
Week 8 -1.9  (1.93) -2.2  (1.92)
Week 9 -1.9  (1.96) -2.3  (1.95)
Week 10 -1.9  (1.98) -2.4  (2.06)
Week 11 -1.9  (1.93) -2.3  (2.12)
Week 12 -1.9  (1.91) -2.4  (2.12)
3.Secondary Outcome
Title Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation
Hide Description 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).
Time Frame Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description:
Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Overall Number of Participants Analyzed 90 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.1  (2.1) -2.5  (2.3)
4.Secondary Outcome
Title Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation
Hide Description 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".
Time Frame Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description:
Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Overall Number of Participants Analyzed 90 89
Measure Type: Number
Unit of Measure: percentage of subjects
47 52
5.Secondary Outcome
Title Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation
Hide Description 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".
Time Frame Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One treated subject had no recorded scores and could not be included. Imputation was a modified LOCF (LOCF for subjects who discontinued early, except if withdrawal was associated with an adverse event (AE) potentially related to study medication, in which case BOCF was used). Additional BOCF analyses have been published (Pain 2012, see citation).
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description:
Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Overall Number of Participants Analyzed 90 89
Measure Type: Number
Unit of Measure: percentage of subjects
32 37
6.Secondary Outcome
Title Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation
Hide Description 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).
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description:
Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Overall Number of Participants Analyzed 90 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.9  (8.5) -9.6  (8.7)
7.Secondary Outcome
Title Change From Baseline in the Brief Pain Inventory Functional Interference Scale at Week 12; mLOCF Imputation
Hide Description

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.

Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description:
Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Overall Number of Participants Analyzed 90 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
-15.1  (14.9) -17.3  (17.5)
8.Secondary Outcome
Title Change From Baseline to Week 12 in Overall Quality of Sleep (Chronic Pain Sleep Inventory)
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description:
Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Overall Number of Participants Analyzed 90 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.7  (33.4) 19.2  (31.3)
9.Secondary Outcome
Title Change From Baseline to Week 12 in the Depression Score of the Hospital Anxiety and Depression Scale (HADS)
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description:
Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Overall Number of Participants Analyzed 90 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.4  (2.6) -0.9  (2.3)
10.Secondary Outcome
Title Change From Baseline to Week 12 in the Anxiety Score of the Hospital Anxiety and Depression Scale (HADS)
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description:
Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Overall Number of Participants Analyzed 90 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.6  (2.67) -1.1  (3.14)
11.Secondary Outcome
Title Change From Baseline to Week 12 in the McGill Pain Questionnaire (Short Form) Total Score
Hide Description 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).
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the active Clonidine Gel group was lost to follow-up before Baseline pain scores were confirmed and before any post-baseline efficacy evaluations were performed. This subject was excluded from the efficacy analyses.
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description:
Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Overall Number of Participants Analyzed 90 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.3  (8.3) -8.7  (9.8)
12.Secondary Outcome
Title Patient Global Impression of Change (PGIC) at Week 12
Hide Description 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.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects with a PGIC score were analyzed.
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description:
Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Overall Number of Participants Analyzed 85 85
Measure Type: Number
Unit of Measure: percentage of subjects
Very Much Improved 11.8 21.2
Much Improved 32.9 27.1
Minimally Improved 31.8 28.2
No Change 21.2 22.4
Minimally Worse 1.2 1.2
Very Much Worse 1.2 0
13.Secondary Outcome
Title Clinician Global Impression of Change (CGIC) at Week 12
Hide Description 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.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects with a CGIC score were analyzed.
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description:
Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Overall Number of Participants Analyzed 85 86
Measure Type: Number
Unit of Measure: percentage of subjects
Very Much Improved 5.8 16.5
Much Improved 38.4 30.6
Minimally Improved 27.9 24.7
No Change 25.6 27.1
Minimally Worse 2.3 1.2
Very Much Worse 0 0
14.Secondary Outcome
Title Change in Blood Pressure From Baseline to Week 12
Hide Description 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.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT (Intent-to-Treat)
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description:
Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
Overall Number of Participants Analyzed 90 90
Mean (Standard Deviation)
Unit of Measure: mmHg
Change in Systolic BP -0.4  (20.6) 1.0  (13.9)
Change in Diastolic BP -0.2  (9.4) 1.0  (8.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Gel Clonidine Topical Gel (ARC-4558)
Hide Arm/Group Description Placebo Gel is vehicle without clonidine Clonidine Topical Gel contains 0.1% clonidine hydrochloride
All-Cause Mortality
Placebo Gel Clonidine Topical Gel (ARC-4558)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Gel Clonidine Topical Gel (ARC-4558)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/90 (3.33%)      3/90 (3.33%)    
Cardiac disorders     
Acute Coronary Syndrome *  0/90 (0.00%)  0 1/90 (1.11%)  1
Atrial Fibrillation *  0/90 (0.00%)  0 1/90 (1.11%)  1
Gastrointestinal disorders     
Abdominal Pain Upper *  1/90 (1.11%)  1 0/90 (0.00%)  0
Pancreatitis Acute *  1/90 (1.11%)  1 0/90 (0.00%)  0
General disorders     
Chest Pain *  1/90 (1.11%)  1 0/90 (0.00%)  0
Infections and infestations     
Abscess Neck *  0/90 (0.00%)  0 1/90 (1.11%)  1
Pneumonia *  0/90 (0.00%)  0 1/90 (1.11%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Gel Clonidine Topical Gel (ARC-4558)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/90 (31.11%)      19/90 (21.11%)    
Gastrointestinal disorders     
Toothache *  1/90 (1.11%)  5/90 (5.56%) 
General disorders     
Pain *  6/90 (6.67%)  0/90 (0.00%) 
Infections and infestations     
Nasopharyngitis *  4/90 (4.44%)  5/90 (5.56%) 
Musculoskeletal and connective tissue disorders     
Pain in Extremity *  7/90 (7.78%)  3/90 (3.33%) 
Nervous system disorders     
Headache *  10/90 (11.11%)  6/90 (6.67%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Investigator may not publish or present any study information without the express written approval of the Sponsor. The Sponsor may withhold approval for publication or presentation.
Results Point of Contact
Name/Title: Dr. James Campbell
Organization: Arcion Therapeutics, Inc.
Phone: (410) 522-8701
Responsible Party: Arcion Therapeutics Inc
ClinicalTrials.gov Identifier: NCT00695565     History of Changes
Other Study ID Numbers: CLO-027
First Submitted: June 10, 2008
First Posted: June 12, 2008
Results First Submitted: July 11, 2013
Results First Posted: November 8, 2016
Last Update Posted: November 8, 2016