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Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

Primary Purpose

Hallux Valgus

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Intranasal Morphine (MNS075) 3.75 mg
Intravenous Morphine 7.5 mg
Intranasal morphine (MNS075) 7.5 mg
Intranasal morphine (MNS075) 15 mg
Intranasal morphine (MNS075) 30 mg
Intranasal placebo
Sponsored by
Javelin Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring Post surgical pain, Bunionectomy, Hammer Toe Syndrome, Morphine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    5

    6

    Arm Description

    Intranasal morphine 3.75 mg

    Intranasal morphine 7.5 mg

    Intranasal morphine 15 mg

    Intranasal morphine 30 mg

    Intravenous morphine 7.5 mg

    Intranasal placebo

    Outcomes

    Primary Outcome Measures

    VAS Total Pain Relief 0-4 hours (TOTPAR4)

    Secondary Outcome Measures

    Other measures of pain relief

    Full Information

    First Posted
    October 12, 2006
    Last Updated
    January 11, 2008
    Sponsor
    Javelin Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00388011
    Brief Title
    Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    August 2005 (Actual)
    Study Completion Date
    August 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Javelin Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hallux Valgus
    Keywords
    Post surgical pain, Bunionectomy, Hammer Toe Syndrome, Morphine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    187 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Intranasal morphine 3.75 mg
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Intranasal morphine 7.5 mg
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    Intranasal morphine 15 mg
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    Intranasal morphine 30 mg
    Arm Title
    5
    Arm Type
    Active Comparator
    Arm Description
    Intravenous morphine 7.5 mg
    Arm Title
    6
    Arm Type
    Placebo Comparator
    Arm Description
    Intranasal placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Intranasal Morphine (MNS075) 3.75 mg
    Intervention Description
    Intranasal Morphine (MNS075) 3.75 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous Morphine 7.5 mg
    Intervention Description
    Intravenous Morphine 7.5 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Intranasal morphine (MNS075) 7.5 mg
    Intervention Description
    Intranasal morphine (MNS075) 7.5 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Intranasal morphine (MNS075) 15 mg
    Intervention Description
    Intranasal morphine (MNS075) 15 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Intranasal morphine (MNS075) 30 mg
    Intervention Description
    Intranasal morphine (MNS075) 30 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Intranasal placebo
    Intervention Description
    Intranasal placebo
    Primary Outcome Measure Information:
    Title
    VAS Total Pain Relief 0-4 hours (TOTPAR4)
    Time Frame
    4 hours
    Secondary Outcome Measure Information:
    Title
    Other measures of pain relief
    Time Frame
    Several time points

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Douglas G Stoker, DPM
    Organizational Affiliation
    Jean Brown Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

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