Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Javelin Pharmaceuticals
• Treatments: Morphine

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