Trial · NCT00695565
Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy
NCT00695565, Phase 2, Completed, Arcion Therapeutics Inc; results first posted 2016-11-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy. Trials, record NCT00695565. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00695565
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy
- NCT number
- NCT00695565
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 180 participants, actual
- Lead sponsor
- Arcion Therapeutics Inc
- Conditions
- Painful Diabetic Neuropathy
- Interventions
- Placebo Gel, Clonidine Topical Gel (ARC-4558)
- First posted
- 2008-06-12
- Last updated
- 2016-11-08
- Results first posted
- 2016-11-08
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation | Baseline (average of Days -7 to -1) and Week 12 (Average of Days 78 to 84) | 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). |
| Secondary | Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation | Baseline (average of Days -7 to -1) and Weeks 1 through 12 (weekly averages) | 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). |
| Secondary | Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation | Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84) | 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). |
| Secondary | Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation | Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84) | 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". |
| Secondary | Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation | Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84) | 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". |
| Secondary | Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation | Baseline and Week 12 | 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). |
| Secondary | Change From Baseline in the Brief Pain Inventory Functional Interference Scale at Week 12; mLOCF Imputation | Baseline and Week 12 | 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. |
| Secondary | Change From Baseline to Week 12 in Overall Quality of Sleep (Chronic Pain Sleep Inventory) | Baseline and Week 12 | 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. |
| Secondary | Change From Baseline to Week 12 in the Depression Score of the Hospital Anxiety and Depression Scale (HADS) | Baseline and Week 12 | 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. |
| Secondary | Change From Baseline to Week 12 in the Anxiety Score of the Hospital Anxiety and Depression Scale (HADS) | Baseline and Week 12 | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation | Baseline (average of Days -7 to -1) and Week 12 (Average of Days 78 to 84) | 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). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation | Baseline (average of Days -7 to -1) and Weeks 1 through 12 (weekly averages) | 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) | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation | Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84) | 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). | units on a scale | MEAN |
| SECONDARY | Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation | Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84) | 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). | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation | Baseline (average of Days -7 to -1) and Week 12 (average of Days 78 to 84) | 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). | percentage of subjects | NUMBER |
| SECONDARY | Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation | Baseline and Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Brief Pain Inventory Functional Interference Scale at Week 12; mLOCF Imputation | Baseline and Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Overall Quality of Sleep (Chronic Pain Sleep Inventory) | Baseline and Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in the Depression Score of the Hospital Anxiety and Depression Scale (HADS) | Baseline and Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in the Anxiety Score of the Hospital Anxiety and Depression Scale (HADS) | Baseline and Week 12 | 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. | units on a scale | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation | Placebo Gel | All subjects | -1.9 | Standard Deviation 1.9 | units on a scale |
| Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation | Clonidine Topical Gel (ARC-4558) | All subjects | -2.4 | Standard Deviation 2.1 | units on a scale |
| Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation | Placebo Gel | Capsaicin response ≥ 2 | -1.5 | Standard Deviation 1.8 | units on a scale |
| Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation | Clonidine Topical Gel (ARC-4558) | Capsaicin response ≥ 2 | -2.7 | Standard Deviation 1.9 | units on a scale |
| Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation | Placebo Gel | Week 1 | -0.6 | Standard Deviation 1.01 | units on a scale |
| Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation | Clonidine Topical Gel (ARC-4558) | Week 1 | -0.7 | Standard Deviation 1.34 | units on a scale |
| Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation | Placebo Gel | Week 2 | -1.0 | Standard Deviation 1.30 | units on a scale |
| Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation | Clonidine Topical Gel (ARC-4558) | Week 2 | -1.0 | Standard Deviation 1.45 | units on a scale |
| Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation | Placebo Gel | Week 3 | -1.2 | Standard Deviation 1.47 | units on a scale |
| Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation | Clonidine Topical Gel (ARC-4558) | Week 3 | -1.5 | Standard Deviation 1.58 | units on a scale |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Gel | 90 | |
| Overall Study | STARTED | Clonidine Topical Gel (ARC-4558) | 90 | |
| Overall Study | COMPLETED | Placebo Gel | 77 | |
| Overall Study | COMPLETED | Clonidine Topical Gel (ARC-4558) | 81 | |
| Overall Study | NOT COMPLETED | Placebo Gel | 13 | |
| Overall Study | NOT COMPLETED | Clonidine Topical Gel (ARC-4558) | 9 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Placebo Gel | 10 | 90 | |
| other | Headache | Nervous system disorders | Clonidine Topical Gel (ARC-4558) | 6 | 90 | |
| other | Pain in Extremity | Musculoskeletal and connective tissue disorders | Placebo Gel | 7 | 90 | |
| other | Pain in Extremity | Musculoskeletal and connective tissue disorders | Clonidine Topical Gel (ARC-4558) | 3 | 90 | |
| other | Pain | General disorders | Placebo Gel | 6 | 90 | |
| other | Pain | General disorders | Clonidine Topical Gel (ARC-4558) | 0 | 90 | |
| other | Nasopharyngitis | Infections and infestations | Placebo Gel | 4 | 90 | |
| other | Nasopharyngitis | Infections and infestations | Clonidine Topical Gel (ARC-4558) | 5 | 90 | |
| other | Toothache | Gastrointestinal disorders | Placebo Gel | 1 | 90 | |
| other | Toothache | Gastrointestinal disorders | Clonidine Topical Gel (ARC-4558) | 5 | 90 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Gel | ||
| Total, all-cause mortality | Clonidine Topical Gel (ARC-4558) | ||
| Total, other adverse events | Placebo Gel | 28 | 90 |
| Total, other adverse events | Clonidine Topical Gel (ARC-4558) | 19 | 90 |
| Total, serious adverse events | Placebo Gel | 3 | 90 |
| Total, serious adverse events | Clonidine Topical Gel (ARC-4558) | 3 | 90 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Clonidine Topical Gel (ARC-4558) vs Placebo Gel: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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