Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery
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
1 other identifier
interventional
187
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2005
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 12, 2006
CompletedFirst Posted
Study publicly available on registry
October 13, 2006
CompletedJanuary 14, 2008
January 1, 2008
7 months
October 12, 2006
January 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VAS Total Pain Relief 0-4 hours (TOTPAR4)
4 hours
Secondary Outcomes (1)
Other measures of pain relief
Several time points
Study Arms (6)
1
EXPERIMENTALIntranasal morphine 3.75 mg
2
EXPERIMENTALIntranasal morphine 7.5 mg
3
EXPERIMENTALIntranasal morphine 15 mg
4
EXPERIMENTALIntranasal morphine 30 mg
5
ACTIVE COMPARATORIntravenous morphine 7.5 mg
6
PLACEBO COMPARATORIntranasal placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- years of age or older
- Moderate to severe pain within eight (8) hours following completion of the required bunionectomy surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas G Stoker, DPM
Jean Brown Research
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 12, 2006
First Posted
October 13, 2006
Study Start
January 1, 2005
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
January 14, 2008
Record last verified: 2008-01