ISRCTN16717773进行中（未招募）未知
Retinoic acid metabolism blocking agents (RAMBAs) to treat osteoarthritis of the hand: A 2-arm double-blind randomised controlled proof of concept study
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 44
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. Participant is able to understand English and is willing and able to give written informed consent for participation in the study including to provide blood samples and donate tissue sample at surgery
- •2. Male or female, aged 18 to 75 years
- •3. Symptomatic and radiographic thumb carpometacarpal (CMC) joint osteoarthritis scheduled for trapeziectomy surgery as part of usual care
- •4. Female participants fulfil either of these criteria:
- •4.1 Are of nonchildbearing potential, defined as:
- •- Aged 45 or over and definitely postmenopausal (defined as > = 2 years without
- •any menses) prior to screening OR
- •- Documented as surgically sterile
- •4.2 Are of childbearing potential and fulfil all four of these criteria as well as the fifth, where relevant:
- •- Are not pregnant and have a negative pregnancy test at screening, and
- •- Agree not to try to become pregnant during the study and for 33 days after the final study medication administration, and
- •- Agree not to breastfeed from screening until 33 days after the final study medication administration.
- •- Agree not to donate ova from screening until 33 days after the final study medication administration.
- •- If heterosexually active, agree to consistently use one form of highly effective birth control from screening until 33 days after the final study medication administration.
- •5. Male participants fulfil both of these criteria:
- •5.1 They and their female spouse/partner(s) who are of childbearing potential agree to use 1 form of highly effective birth control from screening until 93 days after the final study medication administration.
- •5.2 They agree not to donate sperm from screening until 93 days after the final study medication administration.
- •6. The participant agrees not to consume grapefruit or grapefruit juice for the duration of the study
- •7. In the Investigator’s opinion, is able and willing to comply with all study requirements
排除标准
- •Current exclusion criteria as of 05/01/2024:
- •1. Other cause of hand pain including inflammatory arthritis (such as rheumatoid arthritis, psoriatic arthritis, gout)
- •2. Use of one or more prohibited treatments within specified timeframe prior to screening, or not willing to avoid treatment for the duration of the study and for 75 hours after last dose:
- •In the last 3 months:
- •2.1. Retinoids or preparations containing high doses of vitamin A
- •2.2. Systemic immunomodulatory therapy (including systemic corticosteroids, methotrexate, sulfasalazine, hydroxychloroquine or cyclosporin)
- •In the last 6 weeks:
- •2.3. Initiation of or change to systemic hormone replacement therapy (HRT) or the combined oral contraceptive pill
- •2.4. Intra-articular steroid injection to the thumb CMC joint scheduled to undergo surgery
- •Currently receiving treatment with:
- •2.5. the following anticonvulsants: phenytoin, carbamazepine, oxcarbazepine, phenobarbital and other barbiturates
- •2.6. the following antifungals: ketoconazole, itraconazole, voriconazole, fluconazole
- •2.7. the following anti-retrovirals: ritonavir, indinavir, saquinavir, nelfinavir, efavirenz, nevirapine
- •2.8. the following antibiotics: erythromycin, telithromycin, troleandomycin, clarithromycin; rifampicin, rifabutin, isoniazid
- •2.9. the following calcium channel blockers: mibefradil, verapamil, diltiazem
- •2.10. coumarin anticoagulants including warfarin
- •2.11. certain antiemetics: netupitant, aprepitant
- •2.12. the following diabetic therapies: pioglitazone, troglitazone
- •2.13. the following antidepressants: nefazodone, St John’s wort
- •2.14. the following other agents: conivaptan, modafinil
- •3. Presence of one or more medical contraindications to the use of talarozole or placebo:
- •3.1. Known hypersensitivity to drug or excipients in active medication or placebo (gelatin, polyethylene glycol (PEG) 400, PEG 4000)
- •3.2. Liver function tests (any of alanine aminotransferase (ALT), total bilirubin, alkaline phosphatase) > 1.5 times the upper limit of normal at screening or within 4 weeks of screening¥ orhistory of underlying disorder likely to affect liver function during the study (not including gallbladder disease).
- •3.3. Estimated glomerular filtration rate of < 60 mL/min per 1.73 m² at screening or within 4 weeks of screening¥ or history of underlying disorder likely to affect renal function during the study
- •3.4 History of low impact fracture (defined here as a fracture occurring spontaneously, or from a fall no greater than standing height, affecting wrist, hip or spine) or a known diagnosis of osteoporosis
- •3.5 Addison’s disease or any other cause of clinically significant hypoadrenalism
- •3.6 Known infection with Human Immunodeficiency Virus
- •4. Excessively elevated blood lipid levels (a fasting total cholesterol/HDL ratio of >6.0 mmol/L or a fasting triglyceride level of >3.5 mmol/L)¥ or commensurate increases in non-fasting levels
- •5. Bone marrow disorder or clinically significant abnormality on full blood count at screening or within 4 weeks of screening¥.
- •6. Chronic pancreatitis
- •7. Active malignancy or a history of malignancy (except for treated nonmelanoma skin cancer) within the past 5 years, OR any form of chemotherapy.
- •8. Recent history of active cardiovascular disease (within the last 12 months) including clinically significant arrhythmias, symptomatic ischaemic heart disease, myocardial infarction or heart failure (excluding effectively controlled hypertension or treated ischaemic heart disease which is clinica
研究者
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