E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10028395 |
E.1.2 | Term | Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |