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Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery

NCT01436032 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-03-14

No results posted yet for this study

Summary

The purpose of this study is to determine the analgesic efficacy and safety of N1539 in subjects undergoing abdominal laparoscopic surgery.

Conditions

  • Laparoscopic Surgery

Interventions

DRUG

N1539

IV

DRUG

N1539

IV

DRUG

N1539

IV

DRUG

Ketorolac Tromethamine

IV

DRUG

Placebo

IV

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Neil Singla, MD · Lotus Clinical Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

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 NCT01436032 on ClinicalTrials.gov