Clinical trial NCT01345045: A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Neuropathic Pain
Keywords: Diabetic Asymmetric Polyneuropathy
Symmetric Diabetic Proximal Motor Neuropathy
Diabetic Mononeuropathy Simplex,
Diabetic Autonomic Neuropathy,
Diabetic Amyotrophy
Mononeuropathy
Diabetic Neuropathy
Asymmetric Diabetic Proximal Motor Neuropathy
Diabetic Polyneuropathy
Painful
Diabetic Mononeuropathy
Neuralgia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-04-29
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.

Exclusion Criteria:

* Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (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.

Primary outcomes:
measure: A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary
timeFrame: Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)
Secondary outcomes:
measure: Patient's Global Impression of Change
timeFrame: Week 2, Week 4 and Week 6 (End of Study)
measure: Brief Pain Inventory (BPI) (short form) including Severity and Interference
timeFrame: At each visit up to Week 6 (end of Study)
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Baseline, Week 2, Week 4 and Week 6 (end of Study)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Site Reference ID/Investigator# 51807
state: Arkansas
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 51946
state: California
city: Long Beach
country: United States
facility: Site Reference ID/Investigator# 51468
state: California
city: Walnut Creek
country: United States
facility: Site Reference ID/Investigator# 52744
state: California
city: Clearwater
country: United States
facility: Site Reference ID/Investigator# 51079
state: Florida
city: Hialeah
country: United States
facility: Site Reference ID/Investigator# 51076
state: Florida
city: Hollywood
country: United States
facility: Site Reference ID/Investigator# 51945
state: Florida
city: Ocala
country: United States
facility: Site Reference ID/Investigator# 51077
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 51078
state: Florida
city: Brockton
country: United States
facility: Site Reference ID/Investigator# 51804
state: Massachusetts
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 51263
state: Missouri
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 51268
state: Missouri
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 51302
state: Nebraska
city: Flushing
country: United States
facility: Site Reference ID/Investigator# 51271
state: New York
city: Portland
country: United States
facility: Site Reference ID/Investigator# 52743
state: Oregon
city: Altoona
country: United States
facility: Site Reference ID/Investigator# 51806
state: Pennsylvania
city: Tipton
country: United States
facility: Site Reference ID/Investigator# 51265
state: Pennsylvania
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 51548
state: Texas
city: Renton
country: United States
facility: Site Reference ID/Investigator# 51269
state: Washington
city: Hradec Kralove
country: Czech Republic
facility: Site Reference ID/Investigator# 51425
city: Mor Ostrava
country: Czech Republic
facility: Site Reference ID/Investigator# 51426
city: Olomouc
country: Czech Republic
facility: Site Reference ID/Investigator# 51424
city: Prague 10
country: Czech Republic
facility: Site Reference ID/Investigator# 51428
city: Prague 6
country: Czech Republic
facility: Site Reference ID/Investigator# 51423
city: Zlin
country: Czech Republic
facility: Site Reference ID/Investigator# 51427
city: Le Creusot
country: France
facility: Site Reference ID/Investigator# 51924
city: Venissieux
country: France
facility: Site Reference ID/Investigator# 51925
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 51503
city: Duesseldorf
country: Germany
facility: Site Reference ID/Investigator# 51642
city: Mainz
country: Germany
facility: Site Reference ID/Investigator# 51502
city: Muenster
country: Germany
facility: Site Reference ID/Investigator# 52346
city: Guadalajara, Jal.
country: Mexico
facility: Site Reference ID/Investigator# 51505
city: Mexico D.F.
country: Mexico
facility: Site Reference ID/Investigator# 51504
city: Monterrey, N.L.
country: Mexico
facility: Site Reference ID/Investigator# 51522
city: Monterrey, N.L.
country: Mexico
facility: Site Reference ID/Investigator# 51506
Study officials:
affiliation: AbbVie
name: Rachel Duan, MD
role: STUDY_DIRECTOR
References:
citation: Ziegler D, Duan WR, An G, Thomas JW, Nothaft W. A randomized double-blind, placebo-, and active-controlled study of T-type calcium channel blocker ABT-639 in patients with diabetic peripheral neuropathic pain. Pain. 2015 Oct;156(10):2013-2020. doi: 10.1097/j.pain.0000000000000263.