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
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
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
NCT ID
NCT00390312
First Posted
October 17, 2006
Last Updated
December 28, 2007
Sponsor
Javelin Pharmaceuticals
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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