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

Javelin Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Intranasal morphine; Drug: IV morphine; Drug: Placebo; Drug: Intranasal Morphine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00390039

MOR-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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/Exclusion Criteria May Apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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256 participants in 6 patient groups, including a placebo group

A

Experimental group

Description:

MNS075 7.5mg

Treatment:

Drug: Intranasal Morphine

B

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

C

Active Comparator group

Description:

IV Morphine

Treatment:

Drug: IV morphine

E

Experimental group

Description:

MNS075 15mg

Treatment:

Drug: Intranasal morphine

D

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

F

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo