Complex Regional Pain Syndrome type I (CRPS-I) MedDRA version: 17.0 Level: LLT Classification code 10049451 Term: Algodystrophy System Organ Class: 100000004852
Conditions
Interventions
Trade Name: NERIXIA Soluzione iniettabile 25 mg
Product Name: NERIXIA Soluzione iniettabile 25 mg
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Sponsors
Abiogen Pharma SpA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female outpatients aged 18 years or greater; Patients with confirmed diagnosis of CRPS-I according to the International Association for the Study of Pain (IASP) criteria, i.e. the validated Budapest 2007 criteria (Harden et al, 2007, Appendix I) for research purposes and as evidenced by 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 selected extremity (hand, foot, ankle); Opioid analgesics, non-opioid analgesics, NSAIDs, anticonvulsants, antidepressant drugs and other non-drug therapies may be continued during the the double-blind phase provided the dose is stable for at least 4 weeks before treatment start; Women of childbearing potential must have a negative pregnancy test (serum) before entering the study; Women of childbearing potential must agree not to become pregnant and to breastfeed throughout the study period; Patients with a co-operative attitude and able to adhere to study treatment and study protocol procedures and timelines; 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
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 the screening visit (Visit 0); Current signs or symptoms of severe and/or progressive or uncontrolled hepatic, renal, endocrine, haematological, cardiac pulmonary, neurological disease based on investigator judgement; Any other serious medical condition or laboratory abnormality or psychiatric illness preventing the patient from signing the Informed Consent Form; Recent tooth extraction (in the past 3 months prior to Visit 1), unhealed or infected extraction site, significant dental/periodontal disease that may pre-dispose to need for tooth extraction or other invasive dental procedures during the trial; Evidence of denture-related gum trauma or injury; Prior development of an allergic reaction/hypersensitivity while administered bisphosphonates; Prior treatment with bisphosphonates in the previous 12 months; Allergy, sensitivity or intolerance to study drug and/or study drug formulation ingredients; Patients unable to give a valid informed consent; Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; Patients who received any investigational new drug within the last 12 weeks; Patients who have been previously enrolled in this study; Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the efficacy of the investigational medicinal product (IMP) as a proportion of patients showing a 50% or more, reduction of pain intensity, as measured using a 100 mm visual analogic scale (VAS), from the baseline visit to the last visit of the double-blind phase.;Secondary Objective: To assess the improvement in pain intensity over the study period through VAS scale; To assess the improvement in clinical signs and symptoms; To assess the quality of life through generic and specific QoL questionnaires; To assess the rescue analgesic consumption; To assess the safety and local tolerability of Neridronate 25 mg administered by repeated i.m. injections; To assess the effect of treatment on body mass index (BMI); To assess the effect of treatment on the following markers of bone metabolism: serum Type I collagen cross-linked C-telopeptide (CTx); sclerostin, osteocalcin, N-terminal propeptide of type I procollagen (P1NP), recombinant human Dickkopf Homolog 1 (DKK1), parathyroid hormone (PTH) and vitamin D. ;Primary end point(s): The primary efficacy endpoint will be the proportion of patients showing a reduction = 50% of pain intensity graded on a 100 mm VAS scale from baseline to Day 30 (Visit 4). ;Timepoint(s) of evaluation of this end point: See item E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy variables are: Pain graded on a 100 mm VAS scale recorded at the intermediate visits; Clinical signs and symptoms based on a 0-3 rating scale (none, mild, moderate, severe): swelling and pain on passive motion at the intermediate visits; Clinical symptoms based on a dichotomous (present/absent) evaluation: sweating, allodynia and hyperalgesia at the intermediate visits; Mc Gill Pain Questionnaire Short-Form (SF); At visit 0, 1, 4, 5, 6 e 7 Quality of life: SF-36 questionnaire; At visit 0, 1, 4, 5, 6 e 7 Rescue medication consumption: number of tablets of Paracetamol 500 mg administered, reported on a patient daily diary at visit 2, 3, 4; Markers of bone metabolism: serum CTx, sclerostin, osteocalcin, P1NP, DKK1, PTH and vitamin D. At visit 1, 4, 4a (if Applicable), 5, 6, 7 The safety variables of the study are: Adverse Events (AEs) occurring At any time during the study; Hematology and blood chemistry At visit 0, 1, 3, 4, 4a,4d (if Applicable), 5, 6, 7; Physical examination, including measurement of vital signs: weight, height (for BMI assessment), blood pressure and heart rate At visit 0,1, 4, 4a (if Applicable),5, 6, 7; Injection site pain (VAS) At visit 1,2,3; Injection site reddening score: At visit 1,2,3 Injection site hardening score: At visit 1,2,3 ;Timepoint(s) of evaluation of this end point: See item E.5.2 | — |
Countries
Italy
Contacts
Public ContactMarina Accoto
Abiogen Pharma SpA
Outcome results
None listed