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
- 714
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
入选标准
- •1) Male and/or female subject of 18 or greater of age having planned one tooth or two teeth extraction.
- •2) Subject who is on oral anticoagulant and/or antiplatelet therapy at the time of screening.
- •3) Platelet count within 5 days prior to the procedure should be more than 50000 /cubic millimetre (cmm).
- •4) Subject willing to provide written informed consent prior to study.
- •5) Not having taken oral anticoagulant drugs on the day of extraction.
- •6) 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.
- •7) Women of childbearing potential must have negative pregnancy test.
排除标准
- •1) Subject with clinically significant abnormal coagulation tests at the
- •time of screening.
- •2) Female subject, who is pregnant, breastfeeding, or planning to become pregnant during the study period.
- •3) History of hypersensitivity to the study drug or any of the ingredients.
- •4) Subject with International Normalised Ratios (INR) >3.5.
- •5) Subject requiring general anaesthesia or constant sedation.
- •6) 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.
- •7) Subject who has known haemorrhagic diathesis.
- •8) Subject with anaemia (haemoglobin value < 10 g/dL), known liver disease or any medical condition which might affect the coagulation process.
- •9) 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.
- •10) Subject suffering from any psychiatric disease.
- •11) History of uncontrolled diabetes mellitus (HbA1c > 8%).
- •12) Subject suffering with any retinal pathology at the time of screening as per investigator discretion.
- •13) Subject who is undergoing tooth extraction due to trauma.
- •14) Subject who is known case of thyroid disorder.
- •15) 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. Drug abuse is defined as the use of any recreational drug for 5 consecutive days during the 6-month period.
- •16) Smokers; defined as smoking more than 10 cigarettes per day.
- •17) 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.
- •18) Live in the same household as currently randomised subjects.
- •19) Subject who is currently participating in, or had in the 30 days prior to the study participated in an investigational study.
- •20) 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.
- •21) 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.
研究者
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