Painful diabetic neuropathy MedDRA version: 20.0 Level: LLT Classification code 10012683 Term: Diabetic peripheral neuropathy System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10012680 Term: Diabetic neuropathy System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: SOC Classification code 10014698 Term: Endocrine disorders System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: Trittico® 60 mg/ml oral drops, solution
Product Name: Trazodone
Pharmaceutical Form: Oral solution
INN or Proposed INN: Trazodone hydrochloride
CAS Number: 25332-39-2
Current Sponsor code:
Sponsors
Angelini S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patient of any ethnic origin between 18 and 75 years of age (limits included). 2. Patient with painful diabetic symmetric polyneuropathy manifesting with distally distributed neuropathic pain. 3. Stable glycemic control with a value of HbA1c = 10% at Screening Visit. 4. Pain persisting for at least 3 months. 5. Neuropathic pain confirmed by DN4 score = 4 at Screening Visit. 6. BPI-SF 24-hour average pain score (item 5) = 4 at Screening Visit and Baseline Visit 7. Patient who is currently not receiving treatment for diabetic neuropathic pain or patient who is receiving treatment, with drug/s other than gabapentin, and have completed the required washout. 8. Women of childbearing potential must have a negative pregnancy test at Screening Visit and have to agree not to start a pregnancy from the signature of the informed consent up to thirty days after the last administration of the investigational product, using an appropriate birth control method, such as combined estrogen and progestogen containing hormonal contraception (e.g. oral, intravaginal, transdermal), progestogen-only hormonal contraception (e.g. oral, injectable, implantable), intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. 9. Legally capable to give their consent to participate in the study and available to sign and date the 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to trazodone or gabapentin or their excipients. 2. Other forms of neuropathic pain or non-neuropathic pain (included but not limited to peripheral arterial disease, radiculopathy, mononeuropathy, proximal motor neuropathy, post-operative pain, etc). 3. Concomitant treatment with other medications for pain management. 4. Concomitant treatment with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, indinavir) or drugs known to prolong QT interval. 5. Use of trazodone or gabapentin in the previous 3 months. 6. Clinically significant abnormalities on physical examination, vital signs, ECG, laboratory tests at Screening Visit that in the opinion of Investigator would compromise patient’s participation in the study. 7. Active foot ulcer or previous major limb amputation. 8. Myocardial infarction or angioplasty or by-pass graft procedures within the past 6 months. 9. Patient with increased risk of Torsade de Pointes (e.g. family history of long QT syndrome) or QTcF value higher than 450 msec (male) and QTcF value higher than 470 msec (female) at Screening Visit. 10. Transient ischemic attack or cerebral vascular accident within the past 6 months. 11. GFR value < 60 ml/min calculated with MDRD formula. 12. Significant liver disease, defined as known active hepatitis or elevated liver enzymes over 3 fold the upper normal limit of laboratory normal ranges. 13. Patient with latent or known hereditary problems of galactose intolerance or the Lapp lactase deficiency or glucose-galactose malabsorption. 14. Positive urine drug screen for CNS active drugs (cocaine, opioids, amphetamines and cannabinoids) a Screening Visit. 15. Positive present history of glaucoma. 16. Hyperthyroidism, even if pharmacologically corrected. 17. Significant mental disorders. 18. History of seizure events other than a single childhood febrile seizure. 19. History of alcohol or psychoactive substance abuse or addiction. 20. Women during pregnancy or lactation period. 21. Inability to comply with the protocol requirements, instructions or study-related restrictions (e.g. uncooperative attitude, inability to return for study-visits, improbability of completing the clinical study, etc). 22. Subject involved in the conduct of the study (e.g. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel, etc). 23. Participation to an interventional clinical trial within 3 months prior to Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect preliminary information on the effect of low doses of trazodone on pain intensity in patients with painful diabetic neuropathy after 8-week treatment period. ;Secondary Objective: To evaluate the neuropathic pain symptoms, anxiety, sleep, quality of life, safety and tolerability.;Primary end point(s): Change from baseline of the BPI-SF item 5 score at Visit 8 (Day 56 ±2).;Timepoint(s) of evaluation of this end point: Baseline - Visit 8 (Day 56 ±2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline of BPI-SF item 5 score at V1, V2, V3, V4, V5, V6, V7 and V9. • Change from baseline of BPI-SF items 3, 4, 5, 6, 8 and 9 score at V1, V2, V3, V4, V5, V6, V7, V8 and V9. • Change from baseline of NPSI total score at V1, V2, V3, V4, V5, V6, V7, V8 and V9. • Change from baseline in quality of life score (SF-36 short form) at V8. • Change from baseline of HAM-A at V1, V2, V3, V4, V5, V6, V7, V8 and V9. • Change from baseline of Leeds Sleep Evaluation Questionnaire at V1, V2, V3, V4, V5, V6, V7, V8 and V9. • PGIC score at V1, V2, V3, V4, V5, V6, V7, V8 and V9. • Safety and tolerability evaluation. ;Timepoint(s) of evaluation of this end point: • Change from baseline of BPI-SF item 5 score at V1, V2, V3, V4, V5, V6, V7 and V9. • Change from baseline of BPI-SF items 3, 4, 5, 6, 8 and 9 score at V1, V2, V3, V4, V5, V6, V7, V8 and V9. • Change from baseline of NPSI total score at V1, V2, V3, V4, V5, V6, V7, V8 and V9. • Change from baseline in quality of life score (SF-36 short form) at V8. • Change from baseline of HAM-A at V1, V2, V3, V4, V5, V6, V7, V8 and V9. • Change from baseline of Leeds Sleep Evaluation Questionnaire at V1, V2, V3, V4, V5, V6, V7, V8 and V9. • PGIC score at V1, V2, V3, V4, V5, V6, V7, V8 and V9. • Safety and tolerability evaluation. | — |
Countries
Czech Republic, Hungary, Poland
Contacts
Public ContactStudy Manager
A.C.R.A.F. SpA (Angelini SpA)
Outcome results
None listed