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

Randomized, Double-Blind, Active- and Placebo-Controlled Study of Analgesic Efficacy and Safety of Repeated Dosing of MNS075 (Intranasal Morphine), IV Morphine, and Placebo in Acute Post-Operative Pain After Elective Orthopedic Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00390039

Enrollment

256

Registered

2006-10-19

Start date

2006-05-31

Completion date

2006-09-30

Last updated

2008-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Pain, postoperative, Surgery, orthopedic, Morphine

Brief 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.

Detailed description

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.

Interventions

DRUGIntranasal Morphine

MNS075 7.5mg q1h PRN

DRUGPlacebo

IN Placebo q1h PRN

DRUGIV morphine

IV morphine 7.5mg q3h PRN

DRUGIntranasal morphine

MNS075 15mg q3h PRN

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
Other measures of pain	Multiple

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026