Trial · NCT02643251
The Efficacy and Safety of Clonidine Hydrochloride Topical Gel, vs Clonidine Hydrochloride Gel Comparator to Treat Painful Diabetic Neuropathy
NCT02643251, Phase 2, Completed, BioDelivery Sciences International; results first posted 2017-08-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Efficacy and Safety of Clonidine Hydrochloride Topical Gel, vs Clonidine Hydrochloride Gel Comparator to Treat Painful Diabetic Neuropathy. Trials, record NCT02643251. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02643251
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy and Safety of Clonidine Hydrochloride Topical Gel, vs Clonidine Hydrochloride Gel Comparator to Treat Painful Diabetic Neuropathy
- NCT number
- NCT02643251
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 138 participants, actual
- Lead sponsor
- BioDelivery Sciences International
- Conditions
- Painful Diabetic Neuropathy, Diabetic Neuropathy, Neuropathy
- Interventions
- Clonidine Hydrochloride Topical Gel, 0.1%, Clonidine Hydrochloride Gel Comparator
- First posted
- 2015-12-31
- Last updated
- 2017-09-20
- Results first posted
- 2017-08-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score | The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days]) | The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 \[±3 days\]) in the Numeric Pain Rating Scale score assessing the "average pain in the past 24 hours in the painful areas of the feet" averaged over Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the primary efficacy endpoint, the mean change in pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model. |
| Secondary | Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores | The change from Baseline (worse over Day -14 to Day -8) to End-of-Treatment (worse over Days 78 to 84 [±3 days]) | The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (worse score from Day -14 to Day -8) to End-of-Treatment (worse score during Days 78 to 84 \[±3 days\]) in the Numeric Pain Rating Scale score assessing the "worse pain in the past 24 hours in the painful areas of the feet" from Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the primary efficacy endpoint, the mean change in pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model. |
Source ClinicalTrials.gov
Outcomes2
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 Day 84 (Week 12) in Numeric Pain Rating Scale Score | The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days]) | units on a scale | MEAN | |
| SECONDARY | Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores | The change from Baseline (worse over Day -14 to Day -8) to End-of-Treatment (worse over Days 78 to 84 [±3 days]) | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
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 Day 84 (Week 12) in Numeric Pain Rating Scale Score | Clonidine Hydrochloride Topical Gel, 0.1% | -1.2 | Standard Deviation 1.395 | units on a scale | |
| Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score | Clonidine Hydrochloride Gel Comparator | -1.4 | Standard Deviation 1.526 | units on a scale | |
| Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores | Clonidine Hydrochloride Topical Gel, 0.1% | -1.29 | Standard Deviation 1.734 | units on a scale | |
| Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores | Clonidine Hydrochloride Gel Comparator | -1.48 | Standard Deviation 1.667 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clonidine Hydrochloride Topical Gel, 0.1% | 69 | |
| Overall Study | STARTED | Clonidine Hydrochloride Gel Comparator | 69 | |
| Overall Study | COMPLETED | Clonidine Hydrochloride Topical Gel, 0.1% | 58 | |
| Overall Study | COMPLETED | Clonidine Hydrochloride Gel Comparator | 67 | |
| Overall Study | NOT COMPLETED | Clonidine Hydrochloride Topical Gel, 0.1% | 11 | |
| Overall Study | NOT COMPLETED | Clonidine Hydrochloride Gel Comparator | 2 |
Source ClinicalTrials.gov
Adverse events22
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 | Clonidine Hydrochloride Topical Gel, 0.1% | 4 | 69 | 4 |
| other | Headache | Nervous system disorders | Clonidine Hydrochloride Gel Comparator | 2 | 69 | 2 |
| serious | Anemia | Blood and lymphatic system disorders | Clonidine Hydrochloride Topical Gel, 0.1% | 0 | 69 | 0 |
| serious | Anemia | Blood and lymphatic system disorders | Clonidine Hydrochloride Gel Comparator | 1 | 69 | 1 |
| serious | Cardiac Failure Congestive | Cardiac disorders | Clonidine Hydrochloride Topical Gel, 0.1% | 1 | 69 | 1 |
| serious | Cardiac Failure Congestive | Cardiac disorders | Clonidine Hydrochloride Gel Comparator | 0 | 69 | 0 |
| serious | Ventricular tachycardia | Cardiac disorders | Clonidine Hydrochloride Topical Gel, 0.1% | 1 | 69 | 1 |
| serious | Ventricular tachycardia | Cardiac disorders | Clonidine Hydrochloride Gel Comparator | 0 | 69 | 0 |
| serious | Chest Pain | General disorders | Clonidine Hydrochloride Topical Gel, 0.1% | 0 | 69 | 0 |
| serious | Chest Pain | General disorders | Clonidine Hydrochloride Gel Comparator | 1 | 69 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clonidine Hydrochloride Topical Gel, 0.1% | 0 | 69 |
| Total, all-cause mortality | Clonidine Hydrochloride Gel Comparator | 0 | 69 |
| Total, other adverse events | Clonidine Hydrochloride Topical Gel, 0.1% | 4 | 69 |
| Total, other adverse events | Clonidine Hydrochloride Gel Comparator | 2 | 69 |
| Total, serious adverse events | Clonidine Hydrochloride Topical Gel, 0.1% | 2 | 69 |
| Total, serious adverse events | Clonidine Hydrochloride Gel Comparator | 6 | 69 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Clonidine Hydrochloride Topical Gel, 0.1% vs Clonidine Hydrochloride Gel Comparator: deaths from any cause | Trial comparisons |
| Clonidine Hydrochloride Topical Gel, 0.1% vs Clonidine Hydrochloride Gel Comparator: serious adverse events | 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02643251
GET https://conductscience.org/api/trials/v1/NCT02643251/events?page=2