CTRI/2011/11/002156已完成3 期
A double blind, randomized, placebo controlled, parallel group, three arm, multicenter and multinational pivotal study to assess the efficacy and safety of two dosage regimens of Crofelemer tablets in the treatment of moderate to severe acute watery diarrhea in adult patients. - C FORWARD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 717
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 or female patient >=18 to <=65 years.
- •2. Clinical history of >=3 episodes of acute watery diarrhea.
- •3. Moderate to severe diarrhea based on functional impairment.
- •4. Able to comprehend and provide written informed consent for participating in the study, or if in case, the subject is not in the condition to provide written informed consent, consent from Legally Acceptable Representative (LAR) is acceptable.
- •5. Women of childbearing age or potential using adequate contraceptive measures or have been documented to be post menopausal through history taking or having been diagnosed as non pregnant by means of a Urine Pregnancy Test before randomization.
排除标准
- •1. History of receiving antimicrobial or anti diarrheal medication within 6 hours prior to administration of the Investigational Product.
- •2. Patients who have participated in any other interventional clinical trial within the preceding 3 months prior to enrollment in this study.
- •3. Patients with history of significant cardiac, hepatic, renal, cerebrovascular disease and/or other serious illnesses.
- •4. Any other condition which the Investigator feels will pose a significant hazard to the subject if the Investigational Product were to be administered.
- •5. Women who are pregnant or lactating as based on history, physical examination and clinical diagnosis or by means of a Urine Pregnancy Test.
研究者
相似试验
进行中（未招募）
不适用
A double blind, randomized, placebo controlled, parallel group dose range exploration study of Sativex® in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.Pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.EUCTR2007-005225-30-DEGW Pharma Ltd.336
进行中（未招募）
1 期
A double blind, randomized, placebo controlled, parallel group dose range exploration study of Sativex® in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.Estudio doble ciego, aleatorizado, controlado con placebo y en grupos paralelos de búsqueda de dosis de Sativex® para el alivio del dolor en pacientes con cáncer avanzado y analgesia insuficiente durante el tratamiento optimizado permanente con opiáceos.Pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.Dolor en pacientes con cancer avanzado que no gozan de suficiente analgesia durante el tratamiento optimizado permanente con opiáceos.EUCTR2007-005225-30-ESGW Pharma Ltd.336
进行中（未招募）
1 期
A double blind, randomized, placebo controlled, parallel group dose range exploration study of Sativex® in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.Pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.EUCTR2007-005225-30-FRGW Pharma Ltd.336
进行中（未招募）
不适用
A double blind, randomized, placebo controlled, parallel group dose range exploration study of Sativex® in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.Pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.EUCTR2007-005225-30-CZGW Pharma Ltd.336
进行中（未招募）
不适用
A double blind, randomized, placebo controlled, parallel group dose range exploration study of Sativex® in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.Pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.EUCTR2007-005225-30-FIGW Pharma Ltd.336