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
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
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
NCT ID
NCT00388011
First Posted
October 12, 2006
Last Updated
January 11, 2008
Sponsor
Javelin Pharmaceuticals
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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