Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

Hallux Valgus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388011
• Other study ID #: MOR-002
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2006
• Last updated: January 11, 2008
• Start date: January 2005
• Est. completion date: August 2005

Study information

• Verified date: January 2008
• Source: Javelin Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Javelin Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS Total Pain Relief 0-4 hours (TOTPAR4)		4 hours	Yes
Secondary	Other measures of pain relief		Several time points	Yes