CTRI/2010/091/001217已完成4 期
An open label, comparative, multicentric study to evaluate efficacy and safety oflidocaine lozenges vs local lidocaine spray in patients undergoing diagnostic gastroduodenalendoscopy.
Troikaa Pharmaceuticals Ltd Ahmedabad0 个研究点目标入组 250 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Patients of either sex aged 18-80 years.
- •2. Patients undergoing diagnostic gastro-duodenal endoscopy.
排除标准
- •1. Hypersensitivity to lidocaine or any component of the formulation.
- •2. Any contra-indication to lidocaine.
- •3. Application on breached mucous membrane.
- •4. Patients with medical history of respiratory disease such as asthma, bronchitis or chronic obstructive pulmonary disease.
- •5. Use of another topical product at application site.
- •6. Unwilling patients.
- •7. Emergency surgery/ surgery needing hospitalization.
- •8. H/O alcohol or drug abuse.
- •9. Clinically significant impairment of hepatic/renal/cardiac functions.
- •10. Baseline laboratory values outside the clinically acceptable limits.
- •11. Pregnant women and lactating mothers.
- •12. Women of child bearing age not practicing contraception.
- •13. Participation in a clinical study involving an investigational product within past 30 days.
研究者
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