Trial Outcomes & Findings for Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy (NCT NCT02068027)
NCT ID: NCT02068027
Last Updated: 2017-09-26
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.
COMPLETED
PHASE2
260 participants
The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days])
2017-09-26
Participant Flow
Participant milestones
| Measure |
Clonidine Gel 0.1%
Clonidine hydrochloride topical gel, 0.1%
Clonidine Gel 0.1%
|
Placebo
Placebo gel of identical appearance as active treatment
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
130
|
|
Overall Study
COMPLETED
|
117
|
114
|
|
Overall Study
NOT COMPLETED
|
13
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy
Baseline characteristics by cohort
| Measure |
Clonidine Gel 0.1%
n=130 Participants
Clonidine hydrochloride topical gel, 0.1%
Clonidine Gel 0.1%
|
Placebo
n=130 Participants
Placebo gel of identical appearance as active treatment
Placebo
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.58 years
STANDARD_DEVIATION 10.458 • n=5 Participants
|
59.64 years
STANDARD_DEVIATION 11.226 • n=7 Participants
|
60.11 years
STANDARD_DEVIATION 10.838 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
112 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
210 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
95 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
192 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
|
130 participants
n=5 Participants
|
130 participants
n=7 Participants
|
260 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])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.
Outcome measures
| Measure |
Clonidine Gel 0.1%
n=130 Participants
Clonidine hydrochloride topical gel, 0.1%
Clonidine Gel 0.1%
|
Placebo
n=130 Participants
Placebo gel of identical appearance as active treatment
Placebo
|
|---|---|---|
|
Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score
|
-1.6 units on a scale
Standard Deviation 0.17
|
-1.6 units on a scale
Standard Deviation 0.19
|
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 (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.
Outcome measures
| Measure |
Clonidine Gel 0.1%
n=130 Participants
Clonidine hydrochloride topical gel, 0.1%
Clonidine Gel 0.1%
|
Placebo
n=130 Participants
Placebo gel of identical appearance as active treatment
Placebo
|
|---|---|---|
|
Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores
|
-1.4 units on a scale
Standard Deviation 0.11
|
-1.4 units on a scale
Standard Deviation 0.11
|
Adverse Events
Clonidine Gel 0.1%
Placebo
Serious adverse events
| Measure |
Clonidine Gel 0.1%
n=130 participants at risk
Clonidine hydrochloride topical gel, 0.1%
Clonidine Gel 0.1%
|
Placebo
n=130 participants at risk
Placebo gel of identical appearance as active treatment
Placebo
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.77%
1/130 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Cardiac disorders
Bradycardia
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Cardiac disorders
Ischaemic cardiomyophathy
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Gastrointestinal disorders
Oesophagitits
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
General disorders
Non-cardiac chest pain
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
General disorders
Pain
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Nervous system disorders
Ischaemic stroke
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Nervous system disorders
Syncope
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Investigations
Electrocardiogram t wave inversion
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/130
|
0.77%
1/130 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
|
Vascular disorders
Arterial stenosis
|
0.77%
1/130 • Number of events 1
|
0.00%
0/130
|
Other adverse events
| Measure |
Clonidine Gel 0.1%
n=130 participants at risk
Clonidine hydrochloride topical gel, 0.1%
Clonidine Gel 0.1%
|
Placebo
n=130 participants at risk
Placebo gel of identical appearance as active treatment
Placebo
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
7/130 • Number of events 7
|
8.5%
11/130 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Pain in extrimity
|
1.5%
2/130 • Number of events 2
|
6.2%
8/130 • Number of events 8
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
5/130 • Number of events 5
|
5.4%
7/130 • Number of events 7
|
|
Nervous system disorders
Heachache
|
7.7%
10/130 • Number of events 10
|
15.4%
20/130 • Number of events 20
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
2.3%
3/130 • Number of events 3
|
6.2%
8/130 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.4%
7/130 • Number of events 7
|
0.77%
1/130 • Number of events 1
|
|
General disorders
Oedema peripheral
|
5.4%
7/130 • Number of events 7
|
2.3%
3/130 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60