Maintenance of Effect of Duloxetine 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pai

Conditions: Diabetic Peripheral Neuropathic Pain

Registration Number: EUCTR2005-004188-50-DE

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 215

Inclusion Criteria

[1] Male or female outpatients at least 18 years of age.
[2] Present with pain due to bilateral peripheral neuropathy
[3] All females must test negative for a pregnancy test at Visit 1. Females of childbearing potential (not surgically sterilized and between menarche and 1 year
postmenopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Provera® Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia & Upjohn), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.
[4] Score of =4 on the Brief Pain Inventory (BPI) 24-hour average pain item at Visit 2.
[5] Education level and degree of understanding such that they can communicate
intelligibly with the investigator and study coordinator.
[6] Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[7] Are investigator site personnel directly affiliated with the study, or are immediate
family of investigator site personnel directly affiliated with the study.
[8] Are employed by Lilly or Boehringer Ingelheim (BI) (that is, employees, temporary
contract workers, or designees responsible for conducting the study).
[9] Patients who have received treatment within the last 30 days with a drug that has not
received regulatory approval for any indication at the time of study entry (Visit 1).
[10] Patients who have previously completed or withdrawn from this study or any other
study investigating duloxetine or have previously been treated with duloxetine.
[11] Are judged at Visit 1 or Visit 2 to be at suicidal risk by the clinical investigator or as
defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II
(BDI-II).
[12] History of substance abuse or dependence within the past year, excluding nicotine
and caffeine.
[13] A positive urine drug screen for any substances of abuse. Note: If the patient has a
positive urine drug screen at Visit 1 for an excluded medication that may not have had an
adequate washout period, a retest may be performed prior to Visit 2. If the retest is
positive for the parent compound, the patient will be excluded.
[14] Women who are breast-feeding.
[15] Historical exposure to drugs known to cause neuropathy (for example, vincristine),
or a history of a medical condition, including pernicious anemia and hypothyroidism, that
could have been responsible for neuropathy (see Section 5.7).
[16] Pain that cannot be clearly differentiated from or conditions that interfere with the
assessment of the diabetic peripheral neuropathy pain.
[17] Unstable glycemic control as assessed by a physician investigator and a glycosylated
hemoglobin (HbA1c) >12% before Visit 2.
[18] Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness,
symptomatic peripheral vascular disease, or other medical condition or psychiatric
conditions that, in the opinion of investigator, would compromise participation or be
likely to lead to hospitalization during the course of the study.
[19] Acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
[20] Taking any excluded medications that cannot be discontinued at Visit 1.
[21] Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit
2 or the potential need to take during or within 5 days after discontinuation from the
study.
[22] Treatment with fluoxetine within 30 days prior to Visit 2.
[23] Known hypersensitivity to duloxetine or any of the inactive ingredients or patients
with frequent or severe allergic reactions to multiple medications.
[24] Have uncontrolled or poorly controlled hypertension.
[25] Have a seizure disorder.
[26] Have uncontrolled narrow-angle glaucoma.