Diabetec Neuropathic Pain MedDRA version: 14.1 Level: LLT Classification code 10012683 Term: Diabetic peripheral neuropathy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: ABT-639 50mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: N/A
Current Sponsor code: ABT-639
Other descriptive name: ABT-639
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Abbott GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months. Subject must have an average score of = 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from DNP or interfere with the pain assessments of DNP. A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions. Subject has clinically significant abnormalities in clinical laboratory tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of single dose of ABT-639 on spontaneous activity in peripheral C nociceptors measured through microneurography in subjects with painful diabetic peripheral neuropathy (DPN) compared to placebo and lidocaine.;Secondary Objective: To assess the safety, tolerability, and pharmacokinetics of a single dose of ABT 639.;Primary end point(s): Number of Significant Latency Increases (SLI) per minute. Maximum Increase: the largest individual SLI expressed as a percentage of baseline latency. Total Increase: sum of individual SLI increases. Total spikes Spikes/min;Timepoint(s) of evaluation of this end point: Recordings for 10 minute intervals after the oral dose for each C fiber for which microneurography recording is done. Note that recording may be done for a subject on more than one C fiber. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
United Kingdom
Contacts
Public ContactEU Clinical Trials Helpdesk
Abbott Laboratories
Outcome results
None listed