Clinical trial NCT00507936 (phase 2, status: completed)
Conditions: diabetic neuralgia, diabetic neuropathies, diabetic neuropathy, painful, diabetic polyneuropathy, neuralgia, diabetic
ICD codes: G60.8, G58.0, G61.1, A52.15, G60.3, G61.82, H46.2, H46.3
Drugs: abt-894, abt-894, abt-894, placebo, duloxetine
SMILES: ClC1=C(Cl)N=CC(=C1)N1C[C@@H]2CN[C@@H]2C1, ClC1=C(Cl)N=CC(=C1)N1C[C@@H]2CN[C@@H]2C1, ClC1=C(Cl)N=CC(=C1)N1C[C@@H]2CN[C@@H]2C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN(C)CCC[C@]1(OCC2=C1C=CC(=C2)C#N)C1=CC=C(F)C=C1
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).