- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00533793
Adjunctive Therapy to Treat Tibial Shaft Fractures (TSF)
A Phase II Randomized, Controlled, Open-labeled (Dose-blinded) Dose Finding Study of the Safety and Efficacy of I-040202 in the Treatment of Patients With Acute Open Tibial Shaft Fractures
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Plovdiv, Bulgaria, 4002
- MHAT ''Sveti Georgi'', Orthopaedic and Traumatology clinic (85)
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Sofia, Bulgaria, 1606
- MHATEM ''N.I.Pirogov'' Second clinic of Orthopaedic and Traumatology (84)
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Kuopio, Finlandia, 70211
- Finland (71)
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Oulu, Finlandia, 90220
- Finland (72)
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Turku, Finlandia, 20520
- Finland (70)
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Dijon Cedex, Francia, 21079
- France (14)
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Dunkerque, Francia, 59240
- France (16)
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Limoges Cedex, Francia, 87042
- France (15)
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Rouen cedex, Francia, 76031
- France (11)
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Göttingen, Germania, 37075
- Germany (50)
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Kiel, Germania, 24105
- Germany (43)
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Leipzig, Germania, 04103
- Germany (40)
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Ludwigshafen, Germania, 67071
- Germany (41)
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München, Germania, 81377
- Germany (44)
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Ravensburg, Germania, 88212
- Germany (42)
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Rostock, Germania, 18057
- Germany (45)
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Rozzano, Italia, 20089
- Italy (21)
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Brno, Repubblica Ceca, 662 50
- Czech Republic (51)
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Praha, Repubblica Ceca, 150 06
- Czech Republic (52)
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Bucharest, Romania, 014461
- Romania (59)
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Bucharest, Romania, 041915
- Romania (58)
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Bucharest, Romania, 050098
- Spitalul Universitar de Urgenta Bucuresti (87)
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Cluj Napoca, Romania, 400132
- Romania (57)
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Constanta, Romania, 900591
- Spitalul Clinic Judetean Constanta (88)
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Oradea, Romania, 410032
- Romania (73)
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Sibiu, Romania, 550245
- Romania (74)
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Timisoara, Romania, 300736
- Romania (56)
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Belgrade, Serbia, 11000
- Serbia (60)
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Belgrade, Serbia, 11000
- Serbia (76)
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Belgrade, Serbia, 11080
- Serbia (61)
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Kragujevac, Serbia, 34000
- Serbia (62)
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Novi Sad, Serbia, 21000
- Serbia (75)
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Banska Bysterica, Slovacchia, 975 17
- Slovak Republic (65)
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Bratislava 2, Slovacchia, 833 05
- Slovak Republic (64)
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Trnava, Slovacchia, 917 75
- Slovak Republic (77)
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Zilina, Slovacchia, 012 07
- Slovak Republic (63)
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Izola, Slovenia, 6310
- Slovenia (67)
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Novo mesto, Slovenia, 8000
- Slovenia (66)
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Aarau, Svizzera, 5001
- Switzerland (02)
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Davos, Svizzera, 7270
- Switzerland (03)
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Lausanne, Svizzera, 1011
- Switzerland (01)
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Luzern, Svizzera, 6000
- Switzerland (04)
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St. Gallen, Svizzera, 9007
- Switzerland (05)
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Budapest, Ungheria, 1125
- Fovarosi Onkormanyzat Szent janos Korhaza (81)
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Debrecen, Ungheria, 4031
- Hungary (54)
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Esztergom, Ungheria, 2500
- Vaszary Kolos Hospital Esztergom (78)
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Kaposvar, Ungheria, 7500
- Hungary (79)
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Nyiregyhaza, Ungheria, 4400
- Hungary (55)
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Pecs, Ungheria, 7632
- Hungary (53)
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Eligible patients must meet all of the following inclusion criteria:
- patients with an acute open fracture of the tibial shaft secondary to trauma assessed by medical examination and current radiographs indicated for open fracture reduction and internal fixation using osteosynthesis plates or intra-medullary nails
- soft tissue management (if medically warranted, eg. debridement, irrigation, application of antibiotics) performed according to local hospital practice no later than 24h after the trauma
- male and female patients >= 18 years
- body mass index (BMI) 16-33 (minimum body weight 50 kg, maximum 140 kg)
- females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening)
females of child-bearing potential randomized in the intervention group must agree to have acceptable contraception for at least 3 months after receiving the study medication.
Acceptable contraceptive measures are:
- Hormonal types of birth control with a failure rate of less than 1% per year (such as implants, injections, combined oral contraceptives, patches or other methods) or copper IUDs or other IUDs with a failure rate of less than 1% per year, AND
- An additional barrier type of birth control measure (such as condoms, diaphragms, cervical caps, etc.) Sterilized women and abstinent women of child-bearing potential will not be required to take contraceptive measures
- willingness and ability to understand, participate and comply with the study requirements
- patient be able to give consent personally and sign the Informed Consent Form.
Exclusion criteria:
Patients will be not eligible if they meet one of the following exclusion criteria:
- IIIc open fracture according to the Gustilo-Anderson classification
- tibial defects requiring bone-grafting (e.g. large segmental defects)
- duration from trauma to surgery longer than 14 days
- concomitant acute bone injuries and/or major skin or other significant injuries that in the opinion of the investigator would interfere with the tibial shaft fracture healing process
- concomitant ipsilateral tibial fractures other than in the diaphyseal region
- evidence of immune suppression
- suspected or known hypersensitivity to the study medication or components of it
- evidence of hypercalcemia
- hyperparathyroidism
- on treatment and/or planned treatment with products containing PTH (e.g. Forteo)
- pregnant or lactating females
- participation in another clinical trial within the last 3 months
- active or past history of malignant tumor
- history or evidence for any hereditary or acquired chronic metabolic bone disease other than primary osteoporosis.
- history or evidence for any clinically relevant organ failure or any other relevant medical condition that, in the opinion of the investigator, will relevantly interfere with the assessment of study outcome or will impose hazard to the patient if study therapy will be initiated
- known history of allergy to anaesthetics
- evidence of moderate or severe renal failure (serum creatinine > 3.0 times ULN, NCI CTC grades 3 and 4)
- known history of allergic thrombocytopenia (type II) induced by heparin
- inexplicable elevations of alkaline phosphatase or alkaline phosphatase > 5.0 times ULN, NCI CTC grades 3 and 4
- prior external beam or implant radiation therapy to the skeleton
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: SoC
Standard of Care
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internal fracture fixation: osteosynthesis plates or intra-medullary nails
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Comparatore attivo: SoC plus 0.133 mg/mL
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internal fracture fixation: osteosynthesis plates or intra-medullary nails
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Comparatore attivo: SoC plus 0.4 mg/mL
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internal fracture fixation: osteosynthesis plates or intra-medullary nails
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Comparatore attivo: SoC plus 1.0 mg/mL
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internal fracture fixation: osteosynthesis plates or intra-medullary nails
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Clinical Criteria:weight bearing,red.pain,walking without aid;lack of need for surg. interv. fracture site;Radiogr. crit.:Cortical bridging,disintegration/disappearance fracture lines,absence of signs for complications(infection,malunion)
Lasso di tempo: short term follow-up: 6 months; long term follow-up: additional 6 months (total duration of 1 year)
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short term follow-up: 6 months; long term follow-up: additional 6 months (total duration of 1 year)
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Prop. patients healed 3,9,12 mths after T0; prop. time, extent radiogr. union for 2,3,4,5,6,9,12 mths after T0; Eval.:6 and 12 mths; prop./invasiven. sec. interv. due to persistent non-union within 6,12 mths after T0.
Lasso di tempo: short term follow-up: 6 months; long term follow-up: additional 6 months (1 year)
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short term follow-up: 6 months; long term follow-up: additional 6 months (1 year)
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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CS I-040202/01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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