Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

Javelin Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hallux Valgus

Treatments: Drug: Intranasal morphine (MNS075) 7.5 mg; Drug: Intravenous Morphine 7.5 mg; Drug: Intranasal Morphine (MNS075) 3.75 mg; Drug: Intranasal placebo; Drug: Intranasal morphine (MNS075) 30 mg; Drug: Intranasal morphine (MNS075) 15 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00388011

MOR-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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187 participants in 6 patient groups, including a placebo group

1

Experimental group

Description:

Intranasal morphine 3.75 mg

Treatment:

Drug: Intranasal Morphine (MNS075) 3.75 mg

2

Experimental group

Description:

Intranasal morphine 7.5 mg

Treatment:

Drug: Intranasal morphine (MNS075) 7.5 mg

3

Experimental group

Description:

Intranasal morphine 15 mg

Treatment:

Drug: Intranasal morphine (MNS075) 15 mg

4

Experimental group

Description:

Intranasal morphine 30 mg

Treatment:

Drug: Intranasal morphine (MNS075) 30 mg

5

Active Comparator group

Description:

Intravenous morphine 7.5 mg

Treatment:

Drug: Intravenous Morphine 7.5 mg

6

Placebo Comparator group

Description:

Intranasal placebo

Treatment:

Drug: Intranasal placebo