Trial Outcomes & Findings for The Efficacy and Safety of Clonidine Hydrochloride Topical Gel, vs Clonidine Hydrochloride Gel Comparator to Treat Painful Diabetic Neuropathy (NCT NCT02643251)

Last Updated: 2017-09-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

138 participants

Primary outcome timeframe

The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days])

Results posted on

2017-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use.	Clonidine Hydrochloride Gel Comparator Clonidine Hydrochloride Gel Comparator Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.
Overall Study STARTED	69	69
Overall Study COMPLETED	58	67
Overall Study NOT COMPLETED	11	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use.	Clonidine Hydrochloride Gel Comparator Clonidine Hydrochloride Gel Comparator Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.
Overall Study Adverse Event	3	1
Overall Study Withdrawal by Subject	2	0
Overall Study Lost to Follow-up	4	1
Overall Study Protocol Violation	1	0
Overall Study PI Decision to terminate patient	1	0

Baseline Characteristics

The Efficacy and Safety of Clonidine Hydrochloride Topical Gel, vs Clonidine Hydrochloride Gel Comparator to Treat Painful Diabetic Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clonidine Hydrochloride Topical Gel, 0.1% n=69 Participants Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use.	Clonidine Hydrochloride Gel Comparator n=69 Participants Clonidine Hydrochloride Gel Comparator Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.	Total n=138 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants	47 Participants n=7 Participants	98 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Age, Continuous	59.3 years STANDARD_DEVIATION 8.76 • n=5 Participants	59.7 years STANDARD_DEVIATION 10.00 • n=7 Participants	59.5 years STANDARD_DEVIATION 9.37 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	24 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	43 Participants n=7 Participants	92 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants	69 participants n=7 Participants	138 participants n=5 Participants

PRIMARY outcome

Timeframe: The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days])

Outcome measures

Outcome measures
Measure	Clonidine Hydrochloride Topical Gel, 0.1% n=58 Participants Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use.	Clonidine Hydrochloride Gel Comparator n=68 Participants Clonidine Hydrochloride Gel Comparator Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.
Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score	-1.2 units on a scale Standard Deviation 1.395	-1.4 units on a scale Standard Deviation 1.526

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Clonidine Hydrochloride Topical Gel, 0.1% n=58 Participants Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use.	Clonidine Hydrochloride Gel Comparator n=68 Participants Clonidine Hydrochloride Gel Comparator Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.
Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores	-1.29 units on a scale Standard Deviation 1.734	-1.48 units on a scale Standard Deviation 1.667

Adverse Events

Clonidine Hydrochloride Topical Gel, 0.1%

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Clonidine Hydrochloride Gel Comparator

Serious events: 6 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clonidine Hydrochloride Topical Gel, 0.1% n=69 participants at risk Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use.	Clonidine Hydrochloride Gel Comparator n=69 participants at risk Clonidine Hydrochloride Gel Comparator Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.
Blood and lymphatic system disorders Anemia	0.00% 0/69	1.4% 1/69 • Number of events 1
Cardiac disorders Cardiac Failure Congestive	1.4% 1/69 • Number of events 1	0.00% 0/69
Cardiac disorders Ventricular tachycardia	1.4% 1/69 • Number of events 1	0.00% 0/69
General disorders Chest Pain	0.00% 0/69	1.4% 1/69 • Number of events 1
Infections and infestations Perirectal absess	0.00% 0/69	1.4% 1/69 • Number of events 1
Metabolism and nutrition disorders dehydration	1.4% 1/69 • Number of events 1	0.00% 0/69
Metabolism and nutrition disorders Gout	0.00% 0/69	1.4% 1/69 • Number of events 1
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/69	1.4% 1/69 • Number of events 1
Gastrointestinal disorders Diarrhoea	0.00% 0/69	1.4% 1/69 • Number of events 1
Gastrointestinal disorders Pancreatitis	0.00% 0/69	1.4% 1/69 • Number of events 1

Other adverse events

Other adverse events
Measure	Clonidine Hydrochloride Topical Gel, 0.1% n=69 participants at risk Clonidine Hydrochloride Topical Gel, 0.1% Clonidine Hydrochloride Topical Gel, 0.1%: Clonidine Gel is supplied as an aqueous gel formulation for topical use.	Clonidine Hydrochloride Gel Comparator n=69 participants at risk Clonidine Hydrochloride Gel Comparator Clonidine Hydrochloride Gel Comparator: Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.
Nervous system disorders Headache	5.8% 4/69 • Number of events 4	2.9% 2/69 • Number of events 2

Additional Information

Tim Warneke

BDSI

Phone: 919-582-0294

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60