A Phase 2 interventional study of trazodone/gabapentin 2.5/25 mg and trazodone/gabapentin 5/50 mg in Painful Diabetic Neuropathy, sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A. Completed at 30 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-05-27.
Sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A · Phase 2, Interventional, and Treatment
The primary objective of the study is to collect preliminary information on the effect of three doses of trazodone/gabapentin FDC products on pain intensity in patients with painful diabetic neuropathy after 8-week treatment period.
The present phase II study is designed to collect preliminary data on the efficacy and safety of trazodone/gabapentin Fixed-Dose Combination (FDC)products for treatment of patients affected by painful diabetic neuropathy in a randomized controlled clinical trial. Diabetic peripheral neuropathic pain represents an important therapeutic challenge as its pathophysiology is not yet fully understood and pain relief is still unsatisfactory. The pharmacological treatments, with exception to those targeted to the glycemic control, are symptomatic and their use is limited by not universal efficacy, side effects or by the development of tolerance. A wide variety of drugs, used both alone and in combination, has shown to significantly reduce neuropathic pain when compared with placebo in randomized controlled trials, even though pain relief remains inadequate for most of the patients.
In this contest, Angelini S.p.A is developing a fixed-dose combination medicinal product for the treatment of neuropathic pain containing low doses of active ingredients: trazodone, a widely used antidepressant drug, and gabapentin which is indicated for the treatment of neuropathic pain.
617 studies on the registry are indexed under Diabetic Neuropathies; 91 are open to participants now.
This study's enrollment of 240 is above the median of 73 across 510 interventional studies indexed under Diabetic Neuropathies.
Browse Diabetic Neuropathies studies →Aziende Chimiche Riunite Angelini Francesco S.p.A is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
One capsule, three times a day, for 8 weeks. The total daily doses administered will be trazodone 7,5 mg and gabapentin 75 mg.
Drug: trazodone/gabapentin 2.5/25 mg
One capsule, three times a day, for 8 weeks.
Drug: trazodone/gabapentin 5/50 mg
One capsule, three times a day, for 8 weeks.
Drug: trazodone/gabapentin 10/100
Two capsules, three times a day, for 8 weeks.
Drug: Placebo oral capsule
according to the following scheduling dosage regimen: * 100 mg (2 capsules) 3 times a day, from day 0 to day 6 (±1); * 300 mg (1 capsule) 3 times a day, from day 7 (±1) to day 13 (±1); * 400 mg (1 capsule) 3 times a day, from day 14 (±1) to day 20 (±1); * 300 mg (2 capsules) 3 times a day, from day 21 (±1) to day 55 (±2).
Drug: Gabapentin
The total daily doses administered will be trazodone 7,5 mg and gabapentin 75 mg.
The total daily doses administered will be trazodone 15 mg and gabapentin 150 mg.
The total daily doses administered will be trazodone 30 mg and gabapentin 300 mg.
The total daily doses administered will be: * 600 mg from day 0 to day 6 (±1) * 900 mg from day 7 (±1) to day 13 (±1) * 1200 mg from day 14 (±1) to day 20 (±1) * 1800 mg from day 21 (±1) to day 56 (±2)
Also known as: Neurontin
Two capsules, three times a day, for 8 weeks.
Change of the average daily pain score based on the 11-point Numeric Rating Scale (NRS).
The NRS is based on a 11-point from 0 for \[no pain\] to 10 \[worst possible pain\].
Time frame: Baseline - Day 56
Change of the average daily pain score based on the 11-point Numeric Rating Scale (NRS).
The NRS is based on a 11-point from 0 for \[no pain\] to 10 \[worst possible pain\].
Time frame: Baseline - Days 7, 14, 21, 28, 42
Percentage of responder patients
Responder patients are defined as ≥30% and ≥50% reduction from baseline of the average daily pain score based on the 11-point NRS.
Time frame: Baseline - Day 56
Change of the average daily pain score based on the 11-point NRS between gabapentin and placebo as assay sensitivity.
The NRS is based on a 11-point from 0 for \[no pain\] to 10 \[worst possible pain\].
Time frame: Baseline - Day 56
Change of Brief Pain Inventory Short Form (BPI-SF) items 3, 4, 5, 6, 8 and 9 score.
The BPI-SF is a numeric rating scale that assesses the severity of pain, its impact on daily functioning and other aspects of pain (e.g. location of pain, relief from medications). Items use a 0-10 numeric rating scale anchored at zero for "no pain" and 10 for "pain as bad as you can imagine" for Severity, and "does not interfere" to "completely interferes" for Interference.
Time frame: Baseline - Days 28, 56
Change of Neuropathic Pain Symptom Inventory (NPSI) total score.
The NPSI is a self-questionnaire specifically designed to evaluate the different symptoms of neuropathic pain: It includes 10 descriptors plus two temporal items that allow discrimination and quantification of five distinct clinically relevant dimensions of neuropathic pain syndromes.
Time frame: Baseline - Days 28, 56
Change of Beck Depression Inventory - Second Edition (BDI-II)
The BDI-II consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression and scored from 0 to 3.
Time frame: Baseline - Days 28, 56
Change of Hospital Anxiety and Depression Scale (HADS).
The HADS is used to assess the level of anxiety and depression that a patient is experiencing. This is 14-item scale: seven related to the anxiety and seven to depression. Each item is scored from 0 to 3.
Time frame: Baseline - Days 28, 56
Change of Insomnia Severity Index (ISI).
The ISI is a 7-item self-reported instrument measuring the patient's perception of his/her insomnia.Total score ranges from 0-28 and the following categorization is applicable: 0-7 = absence of insomnia; 8-14 = subthreshold insomnia; 15-21 = moderate insomnia; 22-28 = severe insomnia.
Time frame: Baseline - Days 28, 56
Change of Euroqol-5D-5L (EQ-5D-5L)
The EQ-5D-5L consists of the EQ-5D descriptive system (five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression assessed as no problems, slight problems, moderate problems, severe problems and extreme problems) and the EQ visual analogue scale (where the patient self-rates his/her health on a vertical visual analogue scale from 'The best health you can imagine' to 'The worst health you can imagine').
Time frame: Baseline - Days 28, 56
Clinical Global Improvement or Change (CGI-C).
CGI-C provides a global rating of patient's Improvement and scores range from "0 - not assessed" through to "7 - very much worse".
Time frame: Baseline - Days 28, 56
Frequency of adverse events
Monitoring of the treatment related adverse events.
Time frame: 65 days
Plan to share: No
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Aziende Chimiche Riunite Angelini Francesco S.p.A