NCT01589432
Completed
Phase 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
Overview
- Phase
- Phase 2
- Intervention
- ABT-639
- Conditions
- Diabetic Neuropathic Pain
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Spontaneous activity in peripheral c-nociceptors
- Status
- Completed
- Last Updated
- 13 years ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ABT-639
Intervention: ABT-639
Placebo
Intervention: Placebo
Lidocaine
Intervention: Lidocaine
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)
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 ComplicationsDiabetes Mellitus, Type 1Diabetic NeuropathiesNCT05951283Manchester 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