We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00388011
First Posted: October 13, 2006
Last Update Posted: January 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Javelin Pharmaceuticals
  Purpose
Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo in patients with moderate to severe post-surgical pain following orthopedic surgery. After initial dosing, up to six (6) doses of IN MNS075 7.5 mg or 15 mg for up to twenty-four (24) hours will be evaluated. The rescue dose remained the same for each.

Condition Intervention Phase
Hallux Valgus Drug: Intranasal Morphine (MNS075) 3.75 mg Drug: Intravenous Morphine 7.5 mg Drug: Intranasal morphine (MNS075) 7.5 mg Drug: Intranasal morphine (MNS075) 15 mg Drug: Intranasal morphine (MNS075) 30 mg Drug: Intranasal placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo and Comparator-Controlled, Dose-Response Trial of the Efficacy and Safety of Intranasal Morphine, Intravenous Morphine and Placebo in Patients With Moderate to Severe Pain Following Orthopedic Surgery

Resource links provided by NLM:


Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:
  • VAS Total Pain Relief 0-4 hours (TOTPAR4) [ Time Frame: 4 hours ]

Secondary Outcome Measures:
  • Other measures of pain relief [ Time Frame: Several time points ]

Enrollment: 187
Study Start Date: January 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intranasal morphine 3.75 mg
Drug: Intranasal Morphine (MNS075) 3.75 mg
Intranasal Morphine (MNS075) 3.75 mg
Experimental: 2
Intranasal morphine 7.5 mg
Drug: Intranasal morphine (MNS075) 7.5 mg
Intranasal morphine (MNS075) 7.5 mg
Experimental: 3
Intranasal morphine 15 mg
Drug: Intranasal morphine (MNS075) 15 mg
Intranasal morphine (MNS075) 15 mg
Experimental: 4
Intranasal morphine 30 mg
Drug: Intranasal morphine (MNS075) 30 mg
Intranasal morphine (MNS075) 30 mg
Active Comparator: 5
Intravenous morphine 7.5 mg
Drug: Intravenous Morphine 7.5 mg
Intravenous Morphine 7.5 mg
Placebo Comparator: 6
Intranasal placebo
Drug: Intranasal placebo
Intranasal placebo

Detailed Description:

Diagnosis and Main Criteria for Inclusion:

Healthy adult patients (18 to 76 years old), who scored PS-1 to PS-3 according to the American Society of Anesthesiologists Physical Status Classification System, requiring primary, unilateral, first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair without additional collateral procedures.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Requires primary unilateral first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair under regional anesthesia. The patient requires collateral orthopedic surgical procedures other than ipsilateral hammertoe repair may not be enrolled into the study.
  • 18 years of age or older
  • Moderate to severe pain within eight (8) hours following completion of the required bunionectomy surgery

Exclusion Criteria:

  • Allergy to shellfish
  • Signs of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety.
  • Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated

Additional Inclusion/Exclusion Criteria May Apply

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388011


Sponsors and Collaborators
Javelin Pharmaceuticals
Investigators
Principal Investigator: Douglas G Stoker, DPM Jean Brown Research
  More Information

Responsible Party: Amy Cohen/Director, Clinical Operations, Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00388011     History of Changes
Other Study ID Numbers: MOR-002
First Submitted: October 12, 2006
First Posted: October 13, 2006
Last Update Posted: January 14, 2008
Last Verified: January 2008

Keywords provided by Javelin Pharmaceuticals:
Post surgical pain
Bunionectomy
Hammer Toe Syndrome
Morphine

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents