Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Sponsor

AbbVie (prior sponsor, Abbott) (Industry)

Overall Status

Completed

CT.gov ID

NCT00507936

Collaborator

(none)

280

Enrollment

Locations

Arms

Duration (Months)

5.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Neuralgia Diabetic Neuropathies Diabetic Neuropathy, Painful Diabetic Polyneuropathy Neuralgia, Diabetic	Drug: ABT-894 Drug: ABT-894 Drug: ABT-894 Drug: placebo Drug: Duloxetine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A ABT-894 1 mg BID	Drug: ABT-894 ABT-894 1 mg capsule BID throughout treatment period
Experimental: B ABT-894 2 mg BID	Drug: ABT-894 ABT-894 2 mg capsule BID throughout treatment period
Experimental: C ABT-894 4 mg BID	Drug: ABT-894 ABT-894 4 mg capsule BID throughout treatment period
Placebo Comparator: D	Drug: placebo placebo capsule BID throughout the treatment period
Active Comparator: E Duloxetine 60 mg QD	Drug: Duloxetine Duloxetine 60 mg QD throughout treatment period

Outcome Measures

Primary Outcome Measures

Efficacy of each ABT-894 dose (1 mg, 2 mg, or 4 mg BID) versus placebo in the treatment of pain due to DNP [Change from baseline to final 24-hour average pain score]

Secondary Outcome Measures

Proportions of treatment responders; subjects who complete treatment period with 30% improvement [From Baseline to final 24-hour average pain score]
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 [Weekly through treatment phase]
Brief Pain Inventory (BPI) (short form) including Pain Severity [At each visit from Baseline to Week 8 visit]
Clinician Global Impression: Severity (CGI-S) and Patient Global Impression: Change (PGI-C) [At each visit from Baseline to Week 8 visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 5207	Mesa	Arizona	United States	85210
2	Site Reference ID/Investigator# 6053	Phoenix	Arizona	United States	85023
3	Site Reference ID/Investigator# 5206	Little Rock	Arkansas	United States	72205
4	Site Reference ID/Investigator# 7387	North Little Rock	Arkansas	United States	72114
5	Site Reference ID/Investigator# 6052	Anaheim	California	United States	92801
6	Site Reference ID/Investigator# 7064	Garden Grove	California	United States	92845
7	Site Reference ID/Investigator# 8286	National City	California	United States	91950
8	Site Reference ID/Investigator# 5276	Clearwater	Florida	United States	33765
9	Site Reference ID/Investigator# 6781	Hialeah	Florida	United States	33012
10	Site Reference ID/Investigator# 7514	Palm Beach Gardens	Florida	United States	33418
11	Site Reference ID/Investigator# 8113	Tampa	Florida	United States	33603
12	Site Reference ID/Investigator# 6047	Pasadena	Maryland	United States	21122
13	Site Reference ID/Investigator# 5277	Brockton	Massachusetts	United States	02301
14	Site Reference ID/Investigator# 6043	St. Louis	Missouri	United States	63117
15	Site Reference ID/Investigator# 6044	St. Louis	Missouri	United States	63141
16	Site Reference ID/Investigator# 7906	Omaha	Nebraska	United States	68131
17	Site Reference ID/Investigator# 6045	New York	New York	United States	10003
18	Site Reference ID/Investigator# 5946	New York	New York	United States	10022
19	Site Reference ID/Investigator# 5216	New York	New York	United States	10065
20	Site Reference ID/Investigator# 7483	New York	New York	United States	10128
21	Site Reference ID/Investigator# 5947	Cincinnati	Ohio	United States	45245
22	Site Reference ID/Investigator# 6869	Cuyahoga Falls	Ohio	United States	44223
23	Site Reference ID/Investigator# 5217	Portland	Oregon	United States	97239
24	Site Reference ID/Investigator# 7699	Houston	Texas	United States	77074
25	Site Reference ID/Investigator# 5836	San Antonio	Texas	United States	78218
26	Site Reference ID/Investigator# 5899	San Antonio	Texas	United States	78229-4801
27	Site Reference ID/Investigator# 5950	San Antonio	Texas	United States	78229
28	Site Reference ID/Investigator# 7187	San Antonio	Texas	United States	78229
29	Site Reference ID/Investigator# 6054	Seattle	Washington	United States	98104
30	Site Reference ID/Investigator# 8508	Kingston		Canada	K7L 1G1
31	Site Reference ID/Investigator# 8436	Laval		Canada	H7T 2P5
32	Site Reference ID/Investigator# 8481	Winnipeg		Canada	R2V 4W3
33	Site Reference ID/Investigator# 5258	Corbeil Essonnes		France	91106
34	Site Reference ID/Investigator# 7696	Nanterre		France	92104
35	Site Reference ID/Investigator# 5260	Narbonne		France	11108
36	Site Reference ID/Investigator# 5171	Nevers		France	58033
37	Site Reference ID/Investigator# 7115	Nimes		France	30029
38	Site Reference ID/Investigator# 6763	Berlin		Germany	10115
39	Site Reference ID/Investigator# 7117	Essen		Germany	45138
40	Site Reference ID/Investigator# 5034	Frankfurt		Germany	60596
41	Site Reference ID/Investigator# 6760	Heidelberg		Germany	69120
42	Site Reference ID/Investigator# 6732	Mainz		Germany	D - 55116
43	Site Reference ID/Investigator# 5018	Milan		Italy	20132
44	Site Reference ID/Investigator# 5006	Rome		Italy	00133
45	Site Reference ID/Investigator# 8427	Guadalajara		Mexico	44656
46	Site Reference ID/Investigator# 8497	Mexico D.F.		Mexico	C.P. 11650
47	Site Reference ID/Investigator# 8125	Monterrey, N.L.		Mexico	C.P. 64460
48	Site Reference ID/Investigator# 8120	Ponce		Puerto Rico	00717-2075
49	Site Reference ID/Investigator# 8121	San Juan		Puerto Rico	00907