Efficacy of pregabalin and duloxetine in patients with painful diabetic peripheral neuropathy (PDPN): the effect of pain on cognitive function, sleep and quality of life (BLOSSOM)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 310

Inclusion Criteria

1. Female and male patients aged 18-85 years.
2. Patients with a history of type 2 diabetes mellitus according to The
American Diabetes Association
(ADA).
3. Patients with a diagnosis of painful diabetic peripheral neuropathy
(PDPN) caused by type 2 diabetes
mellitus based on Douleur Neuropathique questionnaire
(DN4 =4).
4. Patients whose average pain intensity in PDPN in last 24 hours
(measured by VAS), evaluated on
baseline visit, is equal or more than 40 mm (0 mm ='no
pain' and 100 mm ='worst possible pain').
5. Ability to adhere to trial protocol.
6. Written informed consent.
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

1. Patients who took PDPN medication and/or analgesics on a day of baseline visit. 2. Patients with a known hypersensitivity to duloxetine, pregabalin, paracetamol or tramadol or any of the inactive ingredients or have any contraindication for the use of duloxetine, pregabalin, paracetamol or tramadol.
3. Patients with a history of inadequate pain response (pain reduced was equal or less than 30%) to:
3.1 pregabalin at maximum allowed treatment daily dose 600 mg,
3.2 duloxetine at maximum allowed treatment daily dose 120 mg,
3.3 venlafaxine at maximum allowed treatment daily dose 375 mg,
3.4 gabapentin on daily treatment dose more than 1800 mg
3.5 amitriptilin at maximum allowed treatment daily dose 150 mg.
4. Patients, who are currently treated with a daily dose that exceeds:
4.1 150 mg of pregabalin or
4.2 60 mg of duloxetine or
4.3 150 mg of venlafaxine or
4.4 600 mg of gabapentin.
5. Patients with an uncontrolled type 2 diabetes mellitus
6. The scores of less than 20 on Montreal cognitive assessment (MoCA).
7. Have any other type of neuropatic pain, contrasted to PDPN.
8. Evidence of another cause of distal polyneuropathy other than diabetic.
9. Have a serious (evaluated by physician) unstable cardiovascular (e.g. uncontrolled hypertension), hepatic, renal, respiratory, ophthalmologic, gastrointestinal, or hematologic illness, symptomatic peripheral vascular disease, malignant disease or other medical condition that could lead to hospitalisation during the course of the trial.
10. Have a diagnosis or history of uncontrolled glaucoma.
11. Known or suspected alcohol or drug abuse or addiction (excluding nicotine and caffeine).
12. Patients with any prior history of depression (less than one year after completing the last medical treatment), mania, bipolardisorder, psychosis or schizophrenia.
13. Pregnancy, lactation and women of child-bearing potential without highly effective* or at least acceptable** contraception (according to the Recommendations related to contraception and pregnancy testing in clinical trials).
14. Patients with a history of epilepsy, stroke or neurodegenerative disease.
15. Patients taking Monoamine oxidase (MAO) inhibitors or are within one year of their withdrawal.
16. Acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
17. Patients with suspected Restless leg syndrome (RLS).
18. Abnormal thyroid-stimulating hormone (TSH) concentrations (according to the references value of the local laboratory).
19. Vitamin B12 and folic acid deficiency (according to the reference values of the local laboratory).
20. Surgical procedures planned to occur during trial (patients may be rescreened following completion of and recovery from the surgical procedure).
21. Concomitant treatment that might influence the final therapeutic effect of the tested active substances including non-medical treatments.
22. Patients who under the opinion of the investigator will not be compliant to the treatment or not be able to finish the trial for any other reason.
*Highly effective contraception is:
•combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation(oral, intravaginal, transdermal)
•progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
•intrauterine device (IUD)
•intrauterine hormone-releasing system (IUS)
•bilateral tubal occlusion
•vasectomised partner
•sexual abstinence
**Acceptable contraceptio

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

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