NCT01084161

Study to Evaluate the Efficacy, Safety and Tolerability of N1539

A Randomized Double-Blind, Placebo- and Active-Controlled, Dose-Ranging Study to Evaluate the Analgesic, Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Open Abdominal Hysterectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539 in subjects undergoing open abdominal hysterectomy

Conditions

• Hysterectomy

Interventions

Type	Name	Description
DRUG	N1539	5 mg IV once per day
DRUG	N1539	7.5 mg IV once per day
DRUG	N1539	15 mg IV once per day
DRUG	N1539	30 mg IV once per day
DRUG	placebo	IV placebo once per day
DRUG	Morphine	morphine 10-15 mg IV once per day
DRUG	N1539	60 mg IV once per day

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-03-10
• Last updated: 2011-12-02

Locations

12 sites across 3 countries: Georgia, Poland, Serbia