Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain
This study has been completed.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
First received: July 25, 2007
Last updated: January 15, 2013
Last verified: January 2013
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.
Diabetic Neuropathy, Painful
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||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
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 [ Time Frame: Change from baseline to final 24-hour average pain score ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportions of treatment responders; subjects who complete treatment period with 30% improvement [ Time Frame: From Baseline to final 24-hour average pain score ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Weekly through treatment phase ] [ Designated as safety issue: No ]
- Brief Pain Inventory (BPI) (short form) including Pain Severity [ Time Frame: At each visit from Baseline to Week 8 visit ] [ Designated as safety issue: No ]
- Clinician Global Impression: Severity (CGI-S) and Patient Global Impression: Change (PGI-C) [ Time Frame: At each visit from Baseline to Week 8 visit ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2008 (Final data collection date for primary outcome measure)
ABT-894 1 mg BID
ABT-894 1 mg capsule BID throughout treatment period
ABT-894 2 mg BID
ABT-894 2 mg capsule BID throughout treatment period
ABT-894 4 mg BID
ABT-894 4 mg capsule BID throughout treatment period
Placebo Comparator: D
placebo capsule BID throughout the treatment period
Active Comparator: E
Duloxetine 60 mg QD
Duloxetine 60 mg QD throughout treatment period
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507936
AbbVie (prior sponsor, Abbott)
||Wolfram Nothaft, MD
No publications provided
||AbbVie ( AbbVie (prior sponsor, Abbott) )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 25, 2007
||January 15, 2013
||United States: Food and Drug Administration
Keywords provided by AbbVie:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 22, 2013
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Signs and Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Dopamine Uptake Inhibitors