Diabetic Peripheral Neuropathic Pain
Conditions
Interventions
Product Name: CYMBALTA
Pharmaceutical Form: Capsule, hard
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 [10] Patients who have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate whether an effect of duloxetine 60 mg once daily (QD) is maintained over 6 months of therapy in patients with diabetic peripheral neuropathic pain (DPNP) as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item from baseline of the maintenance therapy phase (Visit 4) to endpoint. Only patients who achieve a =30% reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy will be included in this analysis.;Secondary Objective: To evaluate the efficacy of duloxetine 60 mg QD after 6 months of maintenance therapy in patients who achieve a =30% reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy on the various efficacy measures. To evaluate the efficacy of duloxetine 120 mg QD after 6 months of rescue therapy in patients who do not achieve a =30% reduction on the BPI 24-hour average pain item after 8 weeks of 60 mg acute therapy on various efficacy measures. To evaluate the safety of duloxetine 60 mg QD during 8 weeks of acute therapy, duloxetine 60 mg QD during 6 months of maintenance therapy, and duloxetine 120 mg QD during 6 months of rescue therapy as measured by: Discontinuation rates, TEAEs, Vital signs. ;Primary end point(s): The Brief Pain Inventory (BPI) 24-hour average pain item score is a self- scale that measures the severity of pain over the previous 24-hours. The score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). | — |
Countries
Germany, Italy
Outcome results
None listed