drugset / Trial / NCT02542384
A Study Evaluating the Overall Pain Relief and Safety of Intravenous (IV) CR845 in Patients Undergoing Abdominal Surgery
RandomizedParallel-groupDouble-blindTreatment
Summary
The study schedule is comprised of a 14-day Screening Period, a treatment period and an observation period. All eligible subjects will be randomized into one of 3 treatment groups (1 of 2 dose levels or matched placebo). Study drug CR845 will be administered intravenously prior to surgery, and at specific time intervals post surgery. Additional rescue pain and anti-nausea medication will be made available. Post surgical changes in pain intensity, nausea and vomiting will be assessed.
Timeline
- Start
- 2015-09
- Primary completion
- 2018-04
- Completion
- 2018-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Difelikefalin | Protein / enzyme biologic | 0.5 ug/kg | Intravenous |
| Comparator | Difelikefalin | Protein / enzyme biologic | 1 ug/kg | Intravenous |
Indications
No indication recorded.