NCT01589432CompletedPhase 2
A Randomized, Double-blind, Placebo and Active-controlled Study of the Electrophysiological Effects of ABT-639 on Spontaneous Activity in C-Nociceptors in Patients With Painful Diabetic Peripheral Neuropathy
AbbVie (prior sponsor, Abbott)1 site in 1 country39 target enrollmentStarted: April 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Spontaneous activity in peripheral c-nociceptors
Study Overview
Brief Summary
People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ABT-639
Experimental
Intervention: ABT-639 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Lidocaine
Active Comparator
Intervention: Lidocaine (Drug)
Outcomes
Primary Outcomes
Spontaneous activity in peripheral c-nociceptors
Time Frame: 10 minute intervals over 180 minutes
Spontaneous activity in peripheral c-nociceptor measured through microneurography
Secondary Outcomes
- Pain intensity measurements(hourly for 4 hours)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic PainDiabetic Neuropathic PainNCT01345045AbbVie (prior sponsor, Abbott)193
Not yet recruiting
Not Applicable
Quantifying Artificial Pancreas-related Changes in Diabetic NeuropathyDiabetes ComplicationsDiabetic NeuropathiesDiabetes Mellitus, Type 1NCT05951283Manchester University NHS Foundation Trust102
Completed
Phase 3
Cytoflavin in the Treatment of Patients With Diabetic PolyneuropathyDiabetic NeuropathiesNCT04649203POLYSAN Scientific & Technological Pharmaceutical Company216
Terminated
Phase 2
A 2-part Trial to Learn More About How BAY1817080 Works, How Safe it is, and What the Right Dose is for Participants With Diabetic Neuropathic PainNeuropathic Pain Associated With Diabetic Peripheral NeuropathyNCT04641273Bayer154
Terminated
Phase 2
A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal WoundsDiabetesNCT00598871ReGenTree, LLC12