Trial Outcomes & Findings for A Safety Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Painful Diabetic Neuropathy (NCT NCT02355158)

Last Updated: 2017-09-19

Results Overview

The NPSI is a validated, self-administered questionnaire designed to evaluate the different symptoms of neuropathic pain. Each item is quantified on an 11-point (0-10) numeric scale. The NPSI includes 10 descriptors (plus 2 temporal items) that allow discrimination and quantification of 5 distinct clinically relevant dimensions of neuropathic pain syndromes. The Neuropathic Pain Symptom Inventory (NPSI) is a self-questionnaire designed to evaluate the different symptoms of neuropathic pain, which contains a list of descriptors reflecting spontaneous ongoing or paroxysmal pain, evoked pain (i.e., mechanical and thermal allodynia/hyperalgesia) and dysesthesia/paresthesia. Each of these items is quantified on an 11-point (0-10) numerical scale. NPSI total score was calculated and summarized descriptively at month 12 or the subjects last visit. The total score was calculated and summarized.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

197 participants

Primary outcome timeframe

Month 12 or last visit

Results posted on

2017-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Active Clonidine hydrochloride topical gel, 0.1% clonidine hydrochloride topical gel, 0.1%
Overall Study STARTED	197
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	150

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Painful Diabetic Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=197 Participants Clonidine hydrochloride topical gel, 0.1% clonidine hydrochloride topical gel, 0.1%
Age, Continuous	61.1 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants
Sex: Female, Male Male	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	157 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	47 Participants n=5 Participants
Race (NIH/OMB) White	146 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	197 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 12 or last visit

Population: While 197 subjects received study drug, 172 completed the NPSI at the week 12 visit or at their last visit.

Outcome measures

Outcome measures
Measure	Active n=172 Participants Clonidine hydrochloride topical gel, 0.1% clonidine hydrochloride topical gel, 0.1%
Summary of Neuropathic Pain Symptom Inventory (NPSI)	34.44 units on a scale Standard Deviation 25.13

Adverse Events

Active

Serious events: 23 serious events

Other events: 79 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Active n=197 participants at risk Clonidine hydrochloride topical gel, 0.1% clonidine hydrochloride topical gel, 0.1%
Infections and infestations Pneumonia	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Cardiac disorders Cardiac failure congestive	1.0% 2/197 • Number of events 2 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Cardiac disorders Myodcaridal infarction	1.0% 2/197 • Number of events 2 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Cardiac disorders Atrial fibrillation	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Cardiac disorders Coronary artery occlusion	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Cardiac disorders Tachyarrhythmia	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Infections and infestations Osteomyelitis	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Infections and infestations Staphylococcal abscess	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Infections and infestations Upper respiratory tract infection	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Gastrointestinal disorders Small intestinal obstruction	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Gastrointestinal disorders Vomiting	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
General disorders Death	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
General disorders Non-cardiac chest pain	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Musculoskeletal and connective tissue disorders Costochondritis	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Hepatobiliary disorders Cholecystitis acute	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Injury, poisoning and procedural complications Concussion	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Metabolism and nutrition disorders Obesity	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Psychiatric disorders Psychotic disorder	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Vascular disorders Ischaemic limb pain	0.51% 1/197 • Number of events 1 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.

Other adverse events

Other adverse events
Measure	Active n=197 participants at risk Clonidine hydrochloride topical gel, 0.1% clonidine hydrochloride topical gel, 0.1%
Infections and infestations Upper respiratory tract infection	5.6% 11/197 • Number of events 11 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Musculoskeletal and connective tissue disorders Back pain	8.6% 17/197 • Number of events 17 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Musculoskeletal and connective tissue disorders Arthralgia	6.6% 13/197 • Number of events 13 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 11/197 • Number of events 11 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.
Nervous system disorders Headache	13.7% 27/197 • Number of events 27 • 1 year 7 days An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) may have been any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.

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