Trial · NCT02068027

Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy

NCT02068027, Phase 2, Completed, BioDelivery Sciences International; results first posted 2017-08-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy. Trials, record NCT02068027. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02068027

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy
NCT number: NCT02068027
Status: Completed
Phases: Phase 2
Enrollment: 260 participants, actual
Lead sponsor: BioDelivery Sciences International
Conditions: Painful Diabetic Neuropathy, Diabetic Neuropathy, Neuropathy
Interventions: Clonidine Gel 0.1%, Placebo
First posted: 2014-02-20
Last updated: 2017-09-26
Results first posted: 2017-08-24

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 (worst score from Day -14 to Day -8) to End-of-Treatment (worst score during Days 78 to 84 \[±3 days\]) in the Numeric Pain Rating Scale score assessing the "worst 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 endpoint, the change in worst pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline worst 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	Value	Spread	Units
Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score	Clonidine Gel 0.1%	-1.6	Standard Deviation 0.17	units on a scale
Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score	Placebo	-1.6	Standard Deviation 0.19	units on a scale
Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores	Clonidine Gel 0.1%	-1.4	Standard Deviation 0.11	units on a scale
Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores	Placebo	-1.4	Standard Deviation 0.11	units on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Clonidine Gel 0.1%	130
Overall Study	STARTED	Placebo	130
Overall Study	COMPLETED	Clonidine Gel 0.1%	117
Overall Study	COMPLETED	Placebo	114
Overall Study	NOT COMPLETED	Clonidine Gel 0.1%	13
Overall Study	NOT COMPLETED	Placebo	16

Source ClinicalTrials.gov

Adverse events54

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	Back pain	Musculoskeletal and connective tissue disorders	Clonidine Gel 0.1%	7	130	7
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	11	130	11
other	Pain in extrimity	Musculoskeletal and connective tissue disorders	Clonidine Gel 0.1%	2	130	2
other	Pain in extrimity	Musculoskeletal and connective tissue disorders	Placebo	8	130	8
other	Upper respiratory tract infection	Infections and infestations	Clonidine Gel 0.1%	5	130	5
other	Upper respiratory tract infection	Infections and infestations	Placebo	7	130	7
other	Heachache	Nervous system disorders	Clonidine Gel 0.1%	10	130	10
other	Heachache	Nervous system disorders	Placebo	20	130	20
other	Dry Skin	Skin and subcutaneous tissue disorders	Clonidine Gel 0.1%	3	130	3
other	Dry Skin	Skin and subcutaneous tissue disorders	Placebo	8	130	8

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Clonidine Gel 0.1%	0	130
Total, all-cause mortality	Placebo	0	130
Total, other adverse events	Clonidine Gel 0.1%	38	130
Total, other adverse events	Placebo	58	130
Total, serious adverse events	Clonidine Gel 0.1%	12	130
Total, serious adverse events	Placebo	7	130

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35587172	DERIVED

Source PubMed

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 Gel 0.1% vs Placebo: deaths from any cause	Trial comparisons
Clonidine Gel 0.1% vs Placebo: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02068027

GET https://conductscience.org/api/trials/v1/NCT02068027/events?page=2

API reference For AI assistants