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

Javelin Pharmaceuticals256 enrolled

Overview

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.

Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study of repeated intermittent PRN dosing for 24 hours of Intranasal (IN) Morphine Nasal Spray (MNS075) 7.5 mg and 15 mg, 7.5 mg IV morphine infusions and placebo (either IN or IV), 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

256

Conditions

Pain, Postoperative

Interventions

Intranasal MorphineDRUG

MNS075 7.5mg q1h PRN

PlaceboDRUG

IN Placebo q1h PRN

IV morphineDRUG

IV morphine 7.5mg q3h PRN

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Over 18 years old * Scheduled (within two weeks of the screening visit) to undergo elective orthopedic surgery (e.g., bunionectomy, arthroscopic knee surgery, rotator cuff repair) * Moderate to severe pain within 8 hours following completion of the required surgery Exclusion Criteria: * Previous anaphylactic or serious allergic reaction to shellfish or opioids * History of sleep apnea Other Inclusion/Exclusion Criteria May Apply

Locations (7)

Arizona Research Center

Phoenix, Arizona, United States

HOPE Research Institute

Phoenix, Arizona, United States

Vertex Clinical Research

Bakersfield, California, United States

University Orthopedics Center

State College, Pennsylvania, United States

Outcomes

Primary Outcomes

Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS)

Time frame: Multiple

Secondary Outcomes

Other measures of pain

Time frame: Multiple

Data from ClinicalTrials.gov

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