A 12 weeks open label two parallel groups study to assess the efficacy of orally administered duloxetine 60 mg and 120 mg per day on treatment outcomes in patients with diabetic peripheral neuropatic pain with and without co-morbid major depressive disorder
- Conditions
- Painful diabetic polyneuropathy according to ICD-10 with or without co-morbid Major Depressive Disorder according to ICD-10 (F32 and F33).MedDRA version: 9.1Level: LLTClassification code 10012685Term: Diabetic polyneuropathyMedDRA version: 9.1Level: LLTClassification code 10025453Term: Major depressive disorder NOS
- Registration Number
- EUCTR2008-002731-32-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 166
• Male or female patients of =18 years of age that meet the International Conference of Diseases (ICD-10) criteria for DPNP and have a score of = 4 on the BPI 24-hour average pain item at visit 2.
• To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD (F32 and F33 according to ICD-10). Furthermore, the HAMD-17 scores need to match with the ICD-10 criteria for qualification of the MDD+ (with MDD) or MDD- (without MDD) groups, i.e. a HAMD-17 total score of =16 is required to qualify for MDD+ and <16 for MDD-.
• Patients willing and able to comply with all scheduled visits, tests and procedures required by the protocol
• Informed consent document must be signed at screening visit, in accordance with GCP and local regulatory requirements
• Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. and 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.
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
• Have already a diagnosis of depression and are currently treated for depression, when entering the study.
• Are judged at Visits 1 and 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).
• Had 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.
• Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of the diabetic neuropathy pain. Examples of painful conditions that could be confused with diabetic neuropathy pain include peripheral vascular disease (ischemic pain); neurological disorders unrelated to diabetic neuropathy (for example, phantom limb pain from amputation); skin condition in the area of the neuropathy that could alter sensation (for example, plantar ulcer); other painful conditions, (for example, arthritis).
• Have unstable glycemic control as assessed by glycosylated hemoglobin (HbA1c)
=12% prior to Visit 2.
• Have previously been treated with duloxetine.
• 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).
• Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
• Have a positive urine screen for drug abuse (cannabinoids, cocaine, opiates including methadone, or amphetamines, barbiturates, benzodiazepines) at Visit 1 (screening).
• Have serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition (including unstable hypertension) 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.
• Have acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
• Are taking any excluded medications that cannot be discontinued at Visit 1.
• Received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 2 or the potential need to take within 5 days after discontinuation from the study or may need to use a MAOI during the study.
• Received treatment with fluoxetine within 30 days prior to Visit 2.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method