The Efficacy and Safety of NALDEBAIN for the Treatment of Post-Laparotomy Surgery
Status:
Unknown status
Trial end date:
2018-12-31
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to determine the safety and efficacy of single doses
of intramuscular NALDEBAIN on patients scheduled to undergo elective laparotomy. This will be
performed by administering NALDEBAIN pre-operatively to subjects scheduled to undergo
elective laparotomy, and assessing the safety and efficacy of the drug compared to PCA with
fentanyl. The study will demonstrate whether single use of NALDEBAIN is noninferior to PCA
with fentanyl or not.
Phase:
Phase 4
Details
Lead Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital