diabetic peripheral neuropathic pain (DPNP) MedDRA version: 9.1 Level: LLT Classification code 10054095 Term: Neuropathic pain
Conditions
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] Pain due to bilateral peripheral neuropathy [3] Score of at least 4 on the 24-hour average pain severity score on an 11 point Likert scale (on BPI Modified Short Form) [4] Patient is currently not receiving treatment for DPNP or was receiving treatment for DPNP, with a drug other than pregabalin or duloxetine, and completed the required washout prior to randomisation. [5] Patient has never received treatment with duloxetine or pregabalin. [6] Stable glycaemic control, as assessed by a physician investigator, and HbA1c equal or less than 12% at inclusion. [7] Patient has a level of understanding sufficient to provide written informed consent and to communicate with the investigator and site personnel. [8] Patient is judged to be reliable, agrees to keep all appointments for clinic visits, and agrees to participate in recording responses to questionnaires and other instruments used in this study, as well as all other protocol procedures. [9] All females of child-bearing potential must test negative for pregnancy at inclusion, based on a serum pregnancy test. Females of child-bearing potential must agree to use a medically acceptable and reliable means of birth control during the study and for 1 month following the last dose of study drug. 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: [10] Have a known hypersensitivity to duloxetine or pregabalin or any of the inactive ingredients or have any contraindication for the use of duloxetine or pregabalin. [11] Have uncontrolled narrow-angle glaucoma. [12] Have previously completed or withdrawn from this study or any other study investigating duloxetine or pregabalin or have previously been treated with duloxetine or pregabalin [13] Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 2, or have a potential need to use a MAOI during the study or within 5 days after discontinuation of study drug. [14] Have received fluoxetine within 30 days prior to randomisation. [15]Have acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C). [16] Have a serum creatinine greater than or equal1.5 mg/dL or a creatinine clearance <60 mL/min, at Visit 1. [17] Are judged clinically by the investigator to be at suicidal risk or as defined by a score of 2 or greater on Question 9 of the BDI-II, at inclusion or randomisation. [18] Have current, or a history of, substance abuse or dependence within the past year (e.g. amphetamines, barbiturates, cannabis, cocaine and opiates), excluding nicotine and caffeine. [19] Exclusion criterion [19] has been deleted. [20] Women who are breast-feeding. [21] Have a historical exposure to drugs known to cause neuropathy (for example, vincristine), or a history of a medical condition, including pernicious anaemia and hypothyroidism, that could have been responsible for neuropathy. [22] Have pain that cannot be clearly differentiated from or conditions that interfere with the assessment of the DPNP. [23] Are investigator site personnel directly affiliated with this study and/or their immediate families. [24] Are employed by Lilly or Boehringer Ingelheim [25] At the time of study entry, are currently enrolled in, or have been discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. [26] Have serious or unstable cardiovascular, hepatic, renal, respiratory or haematological illness; symptomatic peripheral vascular disease; a history of seizure disorder; or other medical (including unstable hypertension and not clinically euthyroid) or psychological conditions that, in the opinion of the investigator, would compromise participation or be likely to require hospitalisation during the course of the study. [27] Have a history of frequent and/or severe allergic reactions with multiple medications. [28] Are currently taking any excluded medications that cannot be discontinued at inclusion [29] Have any exclusion criteria required by local law. [30] Have received non-pharmacological treatment for pain within 14 days prior to randomisation, or do not agree to abstain from non-pharmacological treatment during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether treatment at standard doses with duloxetine (60 mg/day) in combination with pregabalin (300 mg/day) is superior to a maximal dose of duloxetine (120 mg/day) or pregabalin (600 mg/day) given as monotherapy, over an 8-week period, in patients with diabetic peripheral neuropathic pain, who don’t respond to a standard dose of either duloxetine or pregabalin after 8 weeks of initial treatment. ;Secondary Objective: •To evaluate the efficacy of a duloxetine and pregabalin standard doses combination therapy versus a maximal dose of monotherapy with either pregabalin or duloxetine: -on the following measures over an 8-week period: Mean change in items of the BPI Modified Short Form Severity and Interference portions, means on the CGI-I and PGI I scales, response rates defined, mean change in pain components on the NPSI questionnaire -on mood symptoms (HADS). -on functional/health outcomes as measured by mean changes on the SDS. •To evaluate the safety of a duloxetine and pregabalin standard doses combination therapy versus a maximal dose of monotherapy with either pregabalin or duloxetine as measured by discontinuation rates, TEAEs and vital signs. •To compare the effect of a maximal dose of duloxetine monotherapy versus a maximal dose of a pregabalin monotherapy versus a standard dose of duloxetine and pregabalin combination therapy on resource utilisation ;Primary end point(s): The BPI Modified Short Form (Cleeland and Ryan 1994) is a self-reported instrument that measures the severity of pain and the interference of pain on function. The primary efficacy measure will be the BPI Modified Short Form 24-hour average pain item score. This measures the severity of pain over the previous 24 hours | — |
Countries
France, Germany, Greece, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed