ISRCTN34217298进行中（未招募）2 期
Randomised controlled trial of PENTOCLO (pentoxifylline, tocopherol and clodronate) in mandibular osteoradionecrosis
niversity of Liverpool0 个研究点目标入组 120 人开始时间: 2022年11月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. A diagnosis of mandibular ORN
- •2. Patients considered suitable for medical management
- •3. Written and informed consent obtained from participant and agreement of participant to comply with the requirements of the study
- •4. Aged 18 years and over
排除标准
- •Current exclusion criteria as of 09/01/2024:
- •1. Cannot swallow tablets
- •2. Prior treatment with PENTOCLO or any element thereof within 12 months of the date of randomisation
- •3. Very early ORN (<20 mm² exposed bone) occurring within 12 months of a dental extraction or other dentoalveolar operation (‘Minor Bone Spicules’)
- •4. Mandibular pathological fracture secondary to ORN
- •5. Indication for mandible resection - i.e. patient for whom the severity of their ORN symptoms already constitute an indication for mandible resection and reconstruction. Typically, these symptoms will include severe pain, repeated infections, significant mobile pathological fracture or distressing fistula)
- •6. Patient has had definitive resection / reconstruction for mandibular ORN -i.e. no longer has exposed necrotic bone present.
- •7. Pregnancy
- •8. Lactation
- •9. Age <18 years
- •10. Acute infection at site of the necrotic bone.
- •11. Contraindications to PENTOCLO medications:
- •11.1. Known hypersensitivity, allergy or anaphylaxis to pentoxifylline, tocopherol or sodium clodronate
- •11.2. Treated hypotension
- •11.3. Severe coronary artery disease, defined as grade IV of the Canadian Cardiology Society Angina Grading
- •11.4. Severe atrial fibrillation, defined as grade 4 on modified CCC-SAF
- •11.5. Myocardial infarction within 6 months
- •11.6. Prior history of extensive retinal haemorrhage
- •11.7. Prior history of intracranial bleeding
- •11.8. Impaired renal function (Creatinine clearance <30 ml/minute, will be formally assessed only if U&E out of reference)
- •11.9. Severe liver failure (class B or C Pugh-Child Score, will be formally assessed only if LFT values, out of reference)
- •11.10. Concomitant prescription of anti-platelet agents: clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, NSAIDs, acetylsalicylates (ASA/LAS) including aspirin >75 mg*, ticlopidine, dipyridamole. (*low dose =75 mg aspirin is permitted)
- •11.11. Concomitant prescription of ketorolac, cimetidine, ciprofloxacin, theophylline, estramustine phosphate
- •11.12. Hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
- •11.13. Concomitant prescription other bisphosphonates e.g. risedronate, alendronate, aIbandronate, zoledronic acid, pamidronate, etidronate or prescription of denosusamab
- •11.14. Concomitant prescription of aminoglycoside antibiotics e.g. gentamicin, tobramycin, amikacin, plazomicin, streptomycin, neomycin, paromomycin
- •Previous exclusion criteria:
- •1. Cannot swallow tablets
- •2. Prior treatment with PENTOCLO or any element thereof within 12 months of the date of randomisation
- •3. Very early ORN (<20 mm² exposed bone) occurring within 12 months of a dental extraction or other dentoalveolar operation (‘Minor Bone Spicules’ see flowchart below)
- •4. Mandibular pathological fracture secondary to ORN
- •5. Extra-oral communicating fistula secondary to ORN
- •6. Prior surgery/jaw resection
- •7. Pregnancy
- •8. Lactation
- •9. Age <18 years
- •10. Acute infection at site of the necrotic bone.
- •11. Contraindications to PENTOCLO medications:
- •11.1. Known hypersensitivity, allergy or anaphylaxis to pentoxifylline, tocopherol or sodium clodronate
- •11.2. Treated hypotension
- •11.3. Severe coronary artery disease, defined as grade IV of the Canadian Cardiology Society Angina Grading
- •11.4. Severe atrial fibrillation, defined as grade 4 on modified CCC-SAF
- •11.5. Myocardial infarction within 6 months
- •11.6. Prior history of extensive retinal haemorrhage
- •11.7. Prior histo
研究者
相似试验
已完成
2 期
Pentoxifylline in the treatment of autismChildhood autism.Childhood autismIRCT138711161556N7Tehran University of Medical Sciences40
已完成
2 期
Comparison of Pentoxiphylline alone against Pentoxiphylline and N acetyl cysteine in Severe alcoholic hepatitisCTRI/2018/03/012577Dr Deepak Suvarna240
尚未招募
Unknown
Randomized controlled trial on the safety of protein restriction in patients with conservative chronic kidney disease patientsconservative chronic kidney disease patientsJPRN-UMIN000050234Osaka General Medhical Center Kidney disesase and Hypertention190
已完成
不适用
Group care exercise class vs individual physiotherapy care for the treatment of pelvic and back pain in pregnancyPelvic girdle pain in pregnancyPregnancy and ChildbirthAbdominal and pelvic painISRCTN26238431Cork University Maternity Hospital (Ireland)226
已完成
不适用
A prospective randomized controlled trial of endoscopic bile duct cannulation by guidewiresBiliary and pancreatic disease required endoscopic bile duct cannulationJPRN-UMIN000010082Showa University School of Medicine300