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A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects with Diabetic Neuropathic Pain

A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects with Diabetic Neuropathic Pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-024359-99-DE
Enrollment
180
Registered
2011-04-11
Start date
Unknown
Completion date
Unknown
Last updated
2012-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathic Pain MedDRA version: 13.1 Level: LLT Classification code 10067547 Term: Diabetic peripheral neuropathic pain System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: ABT-639 Product Code: PRD157986 Pharmaceutical Form: Capsule, hard CAS Number: 1235560-31-2 Current Sponsor code: ABT-639 Concentration unit: mg milligram(s) Concentration type: equal Co
PD-144723 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use

Sponsors

Abbott GmbH & Co. KG
Lead Sponsor

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 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

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

MeasureTime frame
Main Objective: To compare the analgesic efficacy and the safety of ABT-639 (100 mg capsules) administered twice daily to placebo in the treatment of diabetic neuropathic pain (DNP). Pregabalin 150 mg administered twice daily will be assessed for assay sensitivity.;Secondary Objective: To explore the pharmacokinetic and pharmacogenetic characteristics of ABT-639 in the DNP population.;Primary end point(s): The weekly mean of the 24-hour average pain score measured by the 11-point numeric rating Scale and calculated from subject's daily diary. ;Timepoint(s) of evaluation of this end point: Weekly—

Secondary

MeasureTime frame
Secondary end point(s): • Patient’s Global Impression of Change. • Brief Pain Inventory (BPI) (short form) including Severity and Interference • Neuropathic Pain Symptom Inventory (NPSI) • Neuropathic Pain Impact on Quality of Life Questionnaire • Euro-Qol-5D • Quality of Sleep Score from the Daily Sleep Diary • Rescue medication ;Timepoint(s) of evaluation of this end point: Each Study visit—

Countries

Czech Republic, Germany, Mexico, Puerto Rico, United States

Contacts

Public ContactClinical Trial Information Desk

Abbott Laboratories

euclinicaltrials@abbott.com004401628644475

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026