CTRI/2018/02/012211已完成3 期
AN OPEN-LABEL, RANDOMIZED, COMPARATIVE, MULTICENTRIC, PARALLEL GROUP, PHASE-III STUDY TO COMPARE THE EFFICACY AND SAFETY OF TWO SQUIRTS OF DICLOFENAC RECTAL SOLUTION WITH APPLICATOR (DICLOFENAC SODIUM 50 mg/squirt) OF LINCOLN PHARMACEUTICALS LTD, INDIA WITH JONAC SUPPOSITORY (DICLOFENAC SODIUM 100 mg) OF GERMAN REMEDIES (CADILA HEALTHCARE LTD.) IN PATIENTS WITH POST-OPERATIVE PAIN -
incoln Pharmaceuticals Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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.patients undergoing elective day open surgery i.e. Hernia or Standard Appendectomy
- •2.Patients undergoing surgical operation with SPINAL anesthesia
- •3.Patients who have signed and dated their written informed consent prior to initiation of study.
排除标准
- •1.Patients with psychiatric or mental diseases, or unable to follow the requests of the protocol including comprehension of VAS procedure
- •2.Known or suspected hypersensitivity to Diclofenac sodium or tramadol
- •3.Patient with any condition which in the opinion of the investigator makes the patients unsuitable for inclusion
- •4.Patients with a history of malignancy, epilepsy, hematological disorders, hepatic or renal insufficiency, peptic ulcer or active GI bleeding, chronic pain, long-term steroid therapy or continuous usage of analgesic drugs, relevant drug allergies or asthma, uncontrolled hypertension, neurologic or psychological disorders, alcohol abuse, opium addict or using any drug that modifies pain perception and inability to tolerate rectal sodium diclofenac are excluded from the study
- •5.Patients with active or history of recurrent rectal bleeding or hemorrhage.
- •6.Patients with any inflammatory lesions of rectum or anus
- •7.Patients with hypervolemia or dehydration from any cause
- •8.Patients with Severe heart failure
- •9.Patients with history of haemorrhagic diathesis or confirmed or suspected cerebrovascular bleeding
- •10.Patients with prolonged operations associated with a risk of haemorrhage
- •11.The outpatients will be excluded from the study
- •12.Patients without the ability to comply with the study protocol and complete the study in the judgment of the investigator
- •13.Pregnant or breast feeding women
- •14.Females of child bearing potential, not taking adequate contraception
- •15.Any condition or situation which, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study like history of bronchial asthma
研究者
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