Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

Phase 2

Completed

• Conditions: Hallux Valgus
• Interventions: Drug: Intranasal morphine (MNS075) 7.5 mg; Drug: Intranasal Morphine (MNS075) 3.75 mg; Drug: Intranasal morphine (MNS075) 15 mg; Drug: Intravenous Morphine 7.5 mg; Drug: Intranasal placebo; Drug: Intranasal morphine (MNS075) 30 mg

• Registration Number: NCT00388011
• Lead Sponsor: Javelin Pharmaceuticals

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.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2006-10-12
• Study First Submitted QC: 2006-10-12
• Study First Posted: 2006-10-13
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-11
• Last Update Posted: 2008-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Intranasal morphine (MNS075) 7.5 mg	Intranasal morphine 7.5 mg
1	Intranasal Morphine (MNS075) 3.75 mg	Intranasal morphine 3.75 mg
3	Intranasal morphine (MNS075) 15 mg	Intranasal morphine 15 mg
5	Intravenous Morphine 7.5 mg	Intravenous morphine 7.5 mg
6	Intranasal placebo	Intranasal placebo
4	Intranasal morphine (MNS075) 30 mg	Intranasal morphine 30 mg

Primary Outcome Measures

Name	Time	Method
VAS Total Pain Relief 0-4 hours (TOTPAR4)	4 hours

Secondary Outcome Measures

Name	Time	Method
Other measures of pain relief	Several time points