Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery - Full Text View

Sponsored by:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00388011

Purpose

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.

Condition	Intervention	Phase
Hallux Valgus	Drug: 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	Phase II

U.S. FDA Resources

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

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:

VAS Total Pain Relief 0-4 hours (TOTPAR4) [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Other measures of pain relief [ Time Frame: Several time points ] [ Designated as safety issue: Yes ]

Enrollment:	187
Study Start Date:	January 2005
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Intranasal morphine 3.75 mg	Drug: Intranasal Morphine (MNS075) 3.75 mg Intranasal Morphine (MNS075) 3.75 mg
2: Experimental Intranasal morphine 7.5 mg	Drug: Intranasal morphine (MNS075) 7.5 mg Intranasal morphine (MNS075) 7.5 mg
3: Experimental Intranasal morphine 15 mg	Drug: Intranasal morphine (MNS075) 15 mg Intranasal morphine (MNS075) 15 mg
4: Experimental Intranasal morphine 30 mg	Drug: Intranasal morphine (MNS075) 30 mg Intranasal morphine (MNS075) 30 mg
5: Active Comparator Intravenous morphine 7.5 mg	Drug: Intravenous Morphine 7.5 mg Intravenous Morphine 7.5 mg
6: Placebo Comparator Intranasal placebo	Drug: Intranasal placebo Intranasal placebo

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388011

Sponsors and Collaborators

Javelin Pharmaceuticals

Investigators

Principal Investigator:

Douglas G Stoker, DPM

Jean Brown Research

More Information

Responsible Party:	Javelin Pharmaceuticals ( Amy Cohen/Director, Clinical Operations )
Study ID Numbers:	MOR-002
Study First Received:	October 12, 2006
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00388011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Javelin Pharmaceuticals:

Post surgical pain
Bunionectomy
Hammer Toe Syndrome
Morphine

Study placed in the following topic categories:

Hallux Valgus
Morphine
Musculoskeletal Diseases

Pain
Congenital Abnormalities
Foot Deformities

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009