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NCT Number: NCT00390039

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

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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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arizona Research Center, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal Morphine

Drug

MNS075 7.5mg q1h PRN

Placebo

Drug

IN Placebo q1h PRN

IV morphine

Drug

IV morphine 7.5mg q3h PRN

Primary outcomes

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

    Time frame: Multiple

Secondary outcomes

  1. Other measures of pain

    Time frame: Multiple

Sponsors and collaborators

Lead sponsor

Javelin Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Oct 19, 2006
Registry last updated
Jan 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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