| Outcome Measures: |
Primary: • Change from the baseline week to Week 3 in the weekly average daily pain intensity as measured on an 11-point numerical pain scale (NPS), three weeks | Secondary: Change from the baseline week to Week 3 in the weekly maximum daily pain intensity as measured on the NPS, three weeks|Change from the baseline week to Week 3 in the weekly consumption of rescue analgesic (i.e., number of paracetamol 500 mg tablets taken per week), three weeks|• Change from Day 8 (end of baseline week) to Day 29 (24 h after last study drug administration) in Short-Form McGill Pain Questionnaire (SF-MPQ) score, three|Clinician's Global Impression of Change from the baseline week at Day 29 (24 h after last study drug administration), three weeks|Patient's Global Impression of Change from the baseline week at Day 29 (24 h after last study drug administration), three weeks|Change from the baseline week to Week 3 in the weekly Daily Sleep Interference Score, three weeks|Incidence of treatment-emergent AEs (TEAEs), three weeks
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| Locations: |
Diabetes and Endocrinology clinic, Bat-Yamon Medical center, Clalit health services, Bat-Yam, Israel|Diabetes clinic, Lin Medical Center, Haifa, 35152, Israel|Rambam Medical Center, Diabetic Endocrine unit, Haifa, Israel|Wolfson Medical Center, Holon, Israel|Diabetic and Endocrinology clinic, Clalit health services, Jerusalem, 9310609, Israel|Meir Medical Center, Endocrynology, diabetes and metabolism Unit, Kfar-Saba, 44821, Israel|Diabetes Department Migdal Hamea Clalit health services, Tel Aviv, 62038, Israel|DMC Medical Center, Tel-Aviv, 6937947, Israel|Sorasky Medical Center, Diabetic unit, Tel-Aviv, Israel|Ziv Medical Center, Endocrinology Unit, Zefat, Israel
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