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Efficacy and Safety of Intranasal Morphine for Pain After Elective Orthopedic Surgery

NCT00390039 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2008-01-14

No results posted yet for this study

Summary

Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Intranasal Morphine

MNS075 7.5mg q1h PRN

DRUG

Placebo

IN Placebo q1h PRN

DRUG

IV morphine

IV morphine 7.5mg q3h PRN

DRUG

Placebo

IV Placebo q3h PRN

DRUG

Intranasal morphine

MNS075 15mg q3h PRN

DRUG

Placebo

IN Placebo q3h PRN

Sponsors & Collaborators

  • Javelin Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Javelin Pharmaceuticals · Javelin Pharmacueticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2006-09-30
Completion
2006-09-30

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 NCT00390039 on ClinicalTrials.gov