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Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction

Primary Purpose

Post-Operative Pain, Third Molar Extraction

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Intranasal Placebo
Intranasal Morphine 15 mg
Immediate Release Oral Morphine 60 mg
Intravenous morphine
Intranasal morphine 7.5 mg
Oral placebo
Intravenous placebo
Sponsored by
Javelin Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Operative Pain focused on measuring Post operative pain, Third molar extraction, Dental surgery, Morphine

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female 18-40 years of age
  • Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars)
  • Moderate or severe pain within 6 hours of completion of surgery

Exclusion Criteria:

  • Other oral surgical procedures during the same session except the removal of supernumerary third molars
  • Evidence 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
  • Allergy to shellfish

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 7

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Active Comparator

    Placebo Comparator

    Placebo Comparator

    Placebo Comparator

    Arm Label

    4

    1

    2

    3

    5

    6

    7

    Arm Description

    Intravenous morphine

    Intranasal morphine 7.5 mg

    Intranasal morphine 15 mg

    Oral morphine 60 mg

    Intranasal placebo

    Oral placebo

    Intravenous placebo

    Outcomes

    Primary Outcome Measures

    Total pain relief (TOTPAR) at the 0-2 hour time interval calculated as the time-weighted sum of the Pain Relief (PR) scores for the time interval 0-2 hours

    Secondary Outcome Measures

    Other measures of pain relief

    Full Information

    First Posted
    October 17, 2006
    Last Updated
    December 28, 2007
    Sponsor
    Javelin Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00390312
    Brief Title
    Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction
    Official Title
    Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Single Dose Comparison of Analgesic Efficacy and Safety of Intranasal Morphine, Immediate Release Oral Morphine, Intravenous Morphine and Placebo in Postsurgical Dental Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2001 (undefined)
    Primary Completion Date
    November 2001 (Actual)
    Study Completion Date
    November 2001 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Javelin Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.
    Detailed Description
    Diagnosis and Main Criteria for Inclusion: Dental outpatients undergoing the removal of 3 or more third molars (2 of which were required to be mandibular and both must be bony impacted third molars).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-Operative Pain, Third Molar Extraction
    Keywords
    Post operative pain, Third molar extraction, Dental surgery, Morphine

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    4
    Arm Type
    Active Comparator
    Arm Description
    Intravenous morphine
    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Intranasal morphine 7.5 mg
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Intranasal morphine 15 mg
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    Oral morphine 60 mg
    Arm Title
    5
    Arm Type
    Placebo Comparator
    Arm Description
    Intranasal placebo
    Arm Title
    6
    Arm Type
    Placebo Comparator
    Arm Description
    Oral placebo
    Arm Title
    7
    Arm Type
    Placebo Comparator
    Arm Description
    Intravenous placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Intranasal Placebo
    Intervention Description
    Intranasal placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Intranasal Morphine 15 mg
    Intervention Description
    Intranasal Morphine 15 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Immediate Release Oral Morphine 60 mg
    Intervention Description
    Immediate Release Oral Morphine 60 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous morphine
    Intervention Description
    Intravenous morphine 7.5 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Intranasal morphine 7.5 mg
    Intervention Description
    Intranasal morphine 7.5 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Oral placebo
    Intervention Description
    Oral placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous placebo
    Intervention Description
    Intravenous placebo
    Primary Outcome Measure Information:
    Title
    Total pain relief (TOTPAR) at the 0-2 hour time interval calculated as the time-weighted sum of the Pain Relief (PR) scores for the time interval 0-2 hours
    Time Frame
    2 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
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female 18-40 years of age Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars) Moderate or severe pain within 6 hours of completion of surgery Exclusion Criteria: Other oral surgical procedures during the same session except the removal of supernumerary third molars Evidence 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 Allergy to shellfish Additional Inclusion/Exclusion Criteria May Apply
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kyle Christensen, DDS
    Organizational Affiliation
    Jean Brown Associates, Inc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction

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