E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Low Back Pain |
Dolore lombare cronico |
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E.1.1.1 | Medical condition in easily understood language |
Chronic Low Back Pain |
Dolore lombare cronico |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10028395 |
E.1.2 | Term | Musculoskeletal and connective tissue disorders |
E.1.2 | System Organ Class | 10028395 - 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 |
The primary objective for this study is to compare the safety, tolerability and the analgesic efficacy of ABT-110 administered subcutaneously (SC) once every 8 weeks (q8w) for a total of two doses to placebo in subjects with CLBP. |
L’obiettivo primario di questa sperimentazione è di confrontare la sicurezza, la tollerabilità e l’efficacia analgesica di ABT-110, somministrato per via sottocutanea (SC) una volta ogni 8 settimane per un totale di 2 somministrazioni, verso placebo, in soggetti con dolore lombare cronico (CLBP). |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to explore population pharmacokinetics of ABT 110 in subjects with CLBP. |
L’obiettivo secondario di questa sperimentazione è di esplorare la farmacocinetica di popolazione di ABT-110 in soggetti con CLBP. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Between 18 and 70 years of age 2) History of CLBP below the 12th thoracic vertebrae and above the crease of the buttocks, ≥ 6 months duration 3) Requires thereapeutic doses of at least 1 oral analgesic for CLBP (NSAIDS, COX-2 inhibitors, Tramadol or tapentadol, opioids) during the previous 3 months with a stable dose for at least 4 days per week during the 4 weeks prior to Screening |
1. Soggetti di età compresa tra 18 e 70 anni. 2. Soggetti con una storia di CLBP in posizione inferiore alla 12a vertebra toracica e superiore alla piega glutea, con una durata ≥ 6 mesi. 3. Soggetti che necessitano di dosi terapeutiche di almeno 1 analgesico orale per il CLBP (FANS, inibitore di COX-2, Tramadolo o tapentadolo, oppiacei) durante i 3 mesi precedenti, con una dose stabile per almeno 4 giorni la settimana durante le 4 settimane precedenti la visita di Screening |
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E.4 | Principal exclusion criteria |
1) Has CLBP with any of the following a) pain with distal extremity radiation b) pain with radiation and neurologic findings c) spinal nerve root compression 2) Has any of the following spinal cord conditions a) tumor, b) infection of the spinal cord or surrounding structures within the past 5 years, c) spinal stenosis with neurogenic claudication, d) spondylolisthesis with distal radiation and/or neurologic findings, e) seronegative spondylarthropathy 3) Has osteoarthritis of the large joints as evidenced by a) history or prior diagnosis of OA in the knee, hip or shoulder, b) clinical findings consistent with ACR Clinical and Radiographic Criteria for OA of the knee, hip or shoulder, or radiographic findings of OA in the knee, hip or shoulder (Kellgren-Lawrence ≥ 2), 4) History of osteonecrosis or rapidly progressive osteoarthritis in any joint |
1. Soggetti affetti da CLBP con una qualsiasi delle seguenti caratteristiche: • Dolore con irradiazione alle estremità distali; • Dolore con irradiazione e reperti neurologici; • Compressione della radice del nervo spinale. 2. Soggetti con storia di una qualsiasi delle seguenti patologie del midollo spinale: • Tumore; • Infezione del midollo spinale o delle strutture circostanti nei 5 anni precedenti; • Stenosi spinale con claudicatio neurogena; • Spondilolistesi con irradiazione distale e/o reperti neurologici; • Spondiloartropatia sieronegativa. 3. Soggetti affetti da osteoartrosi (OA) delle grandi articolazioni confermata da almeno uno dei seguenti riscontri: • Storia o diagnosi precedente di OA del ginocchio, anca o spalla • Reperti clinici coerenti con i criteri clinici e radiografici ACR di OA del ginocchio, anca o spalla, oppure • Reperti radiografici di OA del ginocchio, anca o spalla (Kellgren-Lawrence ≥ 2). 4. Soggetti con storia di osteonecrosi o di OA a rapida progressione a qualsiasi articolazione |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline to Week 16 in pain intensity as measured by a 100 mm Visual Analog Scale (VAS) |
Variazione, dal basale fino alla settimana 16 dell’intensità del dolore valutata secondo Scala Analogico Visiva (VAS) di 100 mm. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Roland-Morris Disability Questionnaire, EQ-5D-5L, WPAI |
Roland-Morris Disability Questionnaire, EQ-5D-5L, WPAI |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
8 and 16 weeks |
8 e 16 settimane |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 6 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Chile |
Mexico |
Singapore |
South Africa |
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E.8.7 | Trial has a data monitoring committee | Yes |
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
|
The end of trial is defined as the date of the last subject's last visit. |
La conclusione della sperimentazione è definita come la data dell'ultima visita dell'ultimo soggetto. |
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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 | 15 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 15 |
E.8.9.2 | In all countries concerned by the trial days | 0 |