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Study to Evaluate the Efficacy, Safety and Tolerability of N1539

NCT01084161 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 486

Last updated 2011-12-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Georgia
  • Poland
  • Serbia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01084161 on ClinicalTrials.gov