Algodystrophic Syndrome MedDRA version: 9.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: NERIXIA*INFUS IV CONC 2F 100MG
Pharmaceutical Form: Solution for infusion
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of th
Sponsors
ABIOGEN PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients aged 18 years or greater Patients with confirmed diagnosis of AS according to IASP modified criteria and as evidenced by a bone scintigraphy performed within 4 months before study entry. Disease duration ≤ 4 months Patients with spontaneous pain (100 mm VAS scale) > 50 mm in the affected limb (or in the selected limb) Opioid analgesics, non-opioid analgesics, NSAIDs, anticonvulsants, antidepressant drugs and other non-drug therapies may be continued provided the dose is stable for at least 4 weeks before treatment start. Women of childbearing potential must have a negative pregnancy test (urine) before entering the study Women of childbearing potential must agree not to become pregnant and to breastfeed throughout the study period. Signature of written Inform Consent Form before any screening procedures 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
Exclusion criteria
Exclusion criteria: Documented peripheral neuropathy, including diabetic neuropathy and other metabolic or toxic neuropathies Bilirubin, ALT, AST, alkaline phosphatase levels > 2 ULN at Visit 1 Current signs or symptoms of severe and/or progressive or uncontrolled hepatic, renal, endocrine, hematological, cardiac pulmonary, neurological disease Any other serious medical condition or laboratory abnormality or psychiatric illness preventing the patient from signing the Informed Consent Form Prior development of an allergic reaction/hypersensitivity while administered bisphosphonates Prior treatment with neridronate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy in terms of proportion of patients with a 50% reduction of pain intensity compared to baseline measured by VAS 100 mm scale recorded at the last visit of the double-blind phase (day 40).;Secondary Objective: To assess improvement in pain graded on a Vas scale and on a verbal scale To assess improvement in clinical signs and symptoms To assess quality of life through generic and specific questionnaires To assess rescue analgesic consumption To assess the effect of neridronate on body mass index To assess the effect of neridronate on markers of bone turnover To evaluate the safety of neridronate 100 mg in a total treatment course of 400 mg i.v. infusion.;Primary end point(s): Proportion of patients with a 50% decrease from baseline in the Pain evaluation on a 100 mm Vas scale (0= no pain; 100= unbearable pain) recorded at the last visit. | — |
Countries
Italy
Outcome results
None listed