CTRI/2022/09/045136已完成3 期
A Randomised, Double-blind, Multicenter, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Tranexamic Acid Mouthwash of Morningside Healthcare Limited, UK, to Reduce Bleeding in Subjects undergoing Tooth Extraction Who Are on Drugs Affecting Hemostasis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 728
- 试验地点
- 23
- 主要终点
- Number of oral bleeding events
研究概览
简要总结
A Randomised, Double-blind, Multicenter, Placebo-controlled, Parallel study to Evaluate the Efficacy and Safety of Tranexamic Acid Mouthwash of Morningside Healthcare Limited, UK, to Reduce Bleeding in subjects undergoing Tooth Extraction who are on Drugs Affecting Hemostasis. Subjects who meet all criteria will be screened in the study. Total 728 subjects will be enrolled in order to complete the study with at least 582 evaluable subjects.
Subject will be instructed to take 10 ml of the assigned solution measured and keep the solution in the mouth for 2 minutes and then to gently drain the mouthwash from mouth, taking care not to rinse, gargle or forcibly spit the solution. Subjects will be given total 12 doses during the study. Primary endpoint will be number of oral bleeding events observed from Day 1 to Day 7. Secondary endpoint will be proportion of subjects with oral bleeding, bleeding score, Treatment-Emergent Adverse events (TEAEs) and serious adverse events (SAEs), non-oral bleeding, thrombotic events and local irritation related AEs etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and/or female subject of 18 or greater of age having planned one tooth or two teeth extraction.
- •Subject who is on oral anticoagulant and/or antiplatelet therapy at the time of screening.
- •Subject willing to provide written informed consent prior to study.
- •Subject willing and able to take the assigned study medication as directed, comply with all study procedures and commit to come for the follow-up visits for the entire duration of the study.
- •Women of childbearing potential must have negative pregnancy test.
排除标准
- •Subject with clinically significant abnormal coagulation tests at the time of screening.
- •Female subject, who is pregnant, breastfeeding, or planning to become pregnant during the study period.
- •History of hypersensitivity to the study drug or any of the ingredients.
- •Subject with International Normalised Ratios (INR) >3.
- •Subject requiring general anaesthesia or constant sedation.
- •Subject who is on treatment with Non-steroidal Anti-inflammatory Drugs (NSAIDs) except antiplatelet drugs (e.g. aspirin, clopidogrel).
- •Note: If the subject was on any of these drugs, sufficient washout period (of at least 5 half-lives) must have elapsed since the last dose of such drug before tooth extraction.
- •Subject who has known haemorrhagic diathesis.
- •Subject with anaemia (haemoglobin value < 10 g/dL), known liver disease or any medical condition which might affect the coagulation process.
- •Subject with a systolic blood pressure above 150 mmHg or a diastolic blood pressure above 100 mmHg. Note: In case the subject has a blood pressure above the specified values, the subject will be rested for 15 minutes and a second blood pressure value will be obtained.
- •The subject will be considered eligible only if the blood pressure values are within the specified limits.
- •Subject suffering from any psychiatric disease.
- •History of uncontrolled diabetes mellitus (HbA1c > 8%).
- •Subject suffering with any retinal pathology at the time of screening as per investigator discretion.
- •Subject who is undergoing tooth extraction due to trauma.
- •Subject who is known case of thyroid disorder.
- •Subject with known alcohol or drug abuse in the last 6 months.
- •Alcohol abuse is defined as the consumption of more than 3 ounces (about 90 mL) of liquor or spirits or 18 ounces (about 530 mL) of beer per day, for 5 consecutive days during the 6-month period.
- •Smokers; defined as smoking more than 10 cigarettes per day.
- •Employee of the investigator, contract research organisation (CRO), Sponsor who is involved in the study, or an immediate family members (e.g. partner, offspring, parents, siblings or sibling’s offspring) of an employee who is involved in the study.
- •Live in the same household as currently randomised subjects.
- •Subject with historical or current evidence of significant haematologic, hepatic, neurologic, renal, or other diseases that, in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
- •Subject having any other clinically significant finding of the physical examination or laboratory value or any reason which in the opinion of the investigator, would prevent the subject from safely participating in the study.
结局指标
主要结局
Number of oral bleeding events
时间窗: Day 1 to Day 7
次要结局
- Proportion of subjects with early bleeding after extraction.(Till 24 hours after extraction.)
- Number of unplanned interruptions of oral anticoagulant/(antiplatelet therapy.)
- Proportion of subjects with oral bleeding(Day 1 to Day 7)
- Mean procedural bleeding score on visual analogue scale (VAS,(0-10 cm).)
- Number of early bleeding events after extraction.(Till 24 hours after extraction.)
- Proportion of subjects with delayed bleeding.(Day 2 to Day 7.)
- Number of delayed bleeding events.(Day 2 to Day 7.)
- Number of minor, clinically-relevant and major bleeding events.(Day 1 to Day 7.)
- Proportion of subjects with minor, clinically-relevant non-major and major bleeding.
- Proportion of subjects with re-interventions.(Day 1 to Day 7.)
- Number of re-interventions.(Day 1 to Day 7.)
- Proportion of subjects with unplanned interruptions of oral anticoagulant/antiplatelet therapy.(Day 1 to Day 7.)
研究者
研究点 (23)
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