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Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

Information source: Javelin Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hallux Valgus

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

Phase: Phase 2

Status: Completed

Sponsored by: Javelin Pharmaceuticals

Official(s) and/or principal investigator(s):
Douglas G Stoker, DPM, Principal Investigator, Affiliation: Jean Brown Research

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.

Clinical Details

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: VAS Total Pain Relief 0-4 hours (TOTPAR4)

Secondary outcome: Other measures of pain relief

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: January 2005
Ending date: August 2005
Last updated: January 11, 2008

Page last updated: June 20, 2008

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