Status:
COMPLETED
Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery
Lead Sponsor:
Javelin Pharmaceuticals
Conditions:
Hallux Valgus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 S...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT00388011
Start Date
January 1 2005
End Date
August 1 2005
Last Update
January 14 2008
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