Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery
Information source: Javelin Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hallux Valgus
Intervention: Intranasal Morphine (MNS075) 3.75 mg (Drug); Intravenous Morphine 7.5 mg (Drug); Intranasal morphine (MNS075) 7.5 mg (Drug); Intranasal morphine (MNS075) 15 mg (Drug); Intranasal morphine (MNS075) 30 mg (Drug); Intranasal placebo (Drug)
Phase: Phase 2
Sponsored by: Javelin Pharmaceuticals
Official(s) and/or principal investigator(s):
Douglas G Stoker, DPM, Principal Investigator, Affiliation: Jean Brown Research
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.
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: VAS Total Pain Relief 0-4 hours (TOTPAR4)
Secondary outcome: Other measures of pain relief
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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
Additional Inclusion/Exclusion Criteria May Apply
Locations and Contacts
Starting date: January 2005
Ending date: August 2005
Last updated: January 11, 2008