Clinical trial NCT00507936: Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain
Official title: A Global, Multicenter, Randomized, Double-Blind Placebo Controlled Study Comparing the Safety and Efficacy of ABT-894, Duloxetine and Placebo in Subjects With Diabetic Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Neuralgia
Diabetic Neuropathies
Diabetic Neuropathy, Painful
Diabetic Polyneuropathy
Neuralgia, Diabetic
Keywords: Diabetic Neuropathy
Painful
Diabetic Polyneuropathy
Neuralgia
Diabetic
Diabetic Neuropathies
Diabetic Neuralgia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2007-07-27
Enrollment: 280
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: This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD). Approximately 275 subjects will be enrolled into the study at approximately 50 sites in both the United States and Europe. The study will be divided into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an 8-week Treatment Period and a 1-week Follow-up Visit.


Eligibility criteria: Inclusion Criteria:

* If female, subject is either postmenopausal for at least two (2) years or surgically sterile or is practicing at least one (1) method of birth control.
* If female, subject must have negative results for pregnancy tests.
* The subject must have a diagnosis of diabetes mellitus (Type 1 or Type 2) and a diagnosis of DNP.
* Subject's DNP must be present for a minimum of six (6) months and should have begun in the feet with relative symmetrical onset.
* Subject has an HgbA1c \<= 9. Subjects who have an HgbA1c \> 9 and \<= 11 may be included in the study.
* If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method (condom) of birth control for the duration of the study and for 7 days following the last dose of study drug.

Exclusion Criteria:

* The subject has failed previous treatment with duloxetine for DNP.
* Subject has a diagnosis of narrow-angle glaucoma.
* Subject has a history of an allergic reaction or intolerance to duloxetine, acetaminophen, or any other NNR agonist.
* Subject has a diagnosis of fibromyalgia that requires treatment.
* Subject has a functioning implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
* Subject has a history of seizures (febrile may be ok) or major depressive episode within the past two (2) years or major psychiatric disorder including bipolar disorder, schizophrenia or borderline personality disorder.
* Subject has a history of myocardial infarction (MI) within six (6) months of the Screening Visit.
* Subject has unstable angina.
* Subject has ventricular arrhythmia requiring anti-arrhythmic therapy.
* Subject has undergone a cardiac revascularization procedure within 30 days of Screening.
* Subject has uncontrolled hypertension (HTN) defined as a systolic blood pressure (BP) \>= 160 and/or a diastolic blood pressure (BP) \>= 100 at Screening and/or Baseline.
* Subject has a clinically significant abnormal ECG at Screening
* Subject has an active malignancy of any type or has been diagnosed with or treated for cancer within the past 5 years.
* Subject has a positive result for drugs of abuse at Screening with the exception of a positive result for a known prescribed medication.
* Subject's screening laboratory results show hepatitis A, B or C.
* Subject has a known or suspected history of Human Immunodeficiency Virus (HIV).

Primary outcomes:
measure: Efficacy of each ABT-894 dose (1 mg, 2 mg, or 4 mg BID) versus placebo in the treatment of pain due to DNP
timeFrame: Change from baseline to final 24-hour average pain score
Secondary outcomes:
measure: Proportions of treatment responders; subjects who complete treatment period with 30% improvement
timeFrame: From Baseline to final 24-hour average pain score
measure: Mean of 24-hour worst pain severity, average of night pain, and average of morning pain measured by the 11-point Likert scale and from subject's daily diary
timeFrame: Weekly through treatment phase
measure: Brief Pain Inventory (BPI) (short form) including Pain Severity
timeFrame: At each visit from Baseline to Week 8 visit
measure: Clinician Global Impression: Severity (CGI-S) and Patient Global Impression: Change (PGI-C)
timeFrame: At each visit from Baseline to Week 8 visit
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Site Reference ID/Investigator# 5207
state: Arizona
city: Phoenix
country: United States
facility: Site Reference ID/Investigator# 6053
state: Arizona
city: Little Rock
country: United States
facility: Site Reference ID/Investigator# 5206
state: Arkansas
city: North Little Rock
country: United States
facility: Site Reference ID/Investigator# 7387
state: Arkansas
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 6052
state: California
city: Garden Grove
country: United States
facility: Site Reference ID/Investigator# 7064
state: California
city: National City
country: United States
facility: Site Reference ID/Investigator# 8286
state: California
city: Clearwater
country: United States
facility: Site Reference ID/Investigator# 5276
state: Florida
city: Hialeah
country: United States
facility: Site Reference ID/Investigator# 6781
state: Florida
city: Palm Beach Gardens
country: United States
facility: Site Reference ID/Investigator# 7514
state: Florida
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 8113
state: Florida
city: Pasadena
country: United States
facility: Site Reference ID/Investigator# 6047
state: Maryland
city: Brockton
country: United States
facility: Site Reference ID/Investigator# 5277
state: Massachusetts
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 6043
state: Missouri
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 6044
state: Missouri
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 7906
state: Nebraska
city: New York
country: United States
facility: Site Reference ID/Investigator# 6045
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 5946
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 5216
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 7483
state: New York
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 5947
state: Ohio
city: Cuyahoga Falls
country: United States
facility: Site Reference ID/Investigator# 6869
state: Ohio
city: Portland
country: United States
facility: Site Reference ID/Investigator# 5217
state: Oregon
city: Houston
country: United States
facility: Site Reference ID/Investigator# 7699
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 5836
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 5899
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 5950
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 7187
state: Texas
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 6054
state: Washington
city: Kingston
country: Canada
facility: Site Reference ID/Investigator# 8508
city: Laval
country: Canada
facility: Site Reference ID/Investigator# 8436
city: Winnipeg
country: Canada
facility: Site Reference ID/Investigator# 8481
city: Corbeil Essonnes
country: France
facility: Site Reference ID/Investigator# 5258
city: Nanterre
country: France
facility: Site Reference ID/Investigator# 7696
city: Narbonne
country: France
facility: Site Reference ID/Investigator# 5260
city: Nevers
country: France
facility: Site Reference ID/Investigator# 5171
city: Nimes
country: France
facility: Site Reference ID/Investigator# 7115
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 6763
city: Essen
country: Germany
facility: Site Reference ID/Investigator# 7117
city: Frankfurt
country: Germany
facility: Site Reference ID/Investigator# 5034
city: Heidelberg
country: Germany
facility: Site Reference ID/Investigator# 6760
city: Mainz
country: Germany
facility: Site Reference ID/Investigator# 6732
city: Milan
country: Italy
facility: Site Reference ID/Investigator# 5018
city: Rome
country: Italy
facility: Site Reference ID/Investigator# 5006
city: Guadalajara
country: Mexico
facility: Site Reference ID/Investigator# 8427
city: Mexico D.F.
country: Mexico
facility: Site Reference ID/Investigator# 8497
city: Monterrey, N.L.
country: Mexico
facility: Site Reference ID/Investigator# 8125
city: Ponce
country: Puerto Rico
facility: Site Reference ID/Investigator# 8120
city: San Juan
country: Puerto Rico
facility: Site Reference ID/Investigator# 8121
Study officials:
affiliation: AbbVie
name: Wolfram Nothaft, MD
role: STUDY_DIRECTOR
References: