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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

MNS075 7.5mg

Group Type EXPERIMENTAL

Intranasal Morphine

Intervention Type DRUG

MNS075 7.5mg q1h PRN

B

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IN Placebo q1h PRN

C

IV Morphine

Group Type ACTIVE_COMPARATOR

IV morphine

Intervention Type DRUG

IV morphine 7.5mg q3h PRN

E

MNS075 15mg

Group Type EXPERIMENTAL

Intranasal morphine

Intervention Type DRUG

MNS075 15mg q3h PRN

D

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV Placebo q3h PRN

F

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IN Placebo q3h PRN

Interventions

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Intranasal Morphine

MNS075 7.5mg q1h PRN

Intervention Type DRUG

Placebo

IN Placebo q1h PRN

Intervention Type DRUG

IV morphine

IV morphine 7.5mg q3h PRN

Intervention Type DRUG

Placebo

IV Placebo q3h PRN

Intervention Type DRUG

Intranasal morphine

MNS075 15mg q3h PRN

Intervention Type DRUG

Placebo

IN Placebo q3h PRN

Intervention Type DRUG

Eligibility Criteria

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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