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Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

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ClinicalTrials.gov Identifier: NCT00388011
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : January 14, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment 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 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2005
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Intranasal morphine 3.75 mg
Drug: Intranasal Morphine (MNS075) 3.75 mg
Intranasal Morphine (MNS075) 3.75 mg

Experimental: 2
Intranasal morphine 7.5 mg
Drug: Intranasal morphine (MNS075) 7.5 mg
Intranasal morphine (MNS075) 7.5 mg

Experimental: 3
Intranasal morphine 15 mg
Drug: Intranasal morphine (MNS075) 15 mg
Intranasal morphine (MNS075) 15 mg

Experimental: 4
Intranasal morphine 30 mg
Drug: Intranasal morphine (MNS075) 30 mg
Intranasal morphine (MNS075) 30 mg

Active Comparator: 5
Intravenous morphine 7.5 mg
Drug: Intravenous Morphine 7.5 mg
Intravenous Morphine 7.5 mg

Placebo Comparator: 6
Intranasal placebo
Drug: Intranasal placebo
Intranasal placebo




Primary Outcome Measures :
  1. VAS Total Pain Relief 0-4 hours (TOTPAR4) [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. Other measures of pain relief [ Time Frame: Several time points ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388011


Sponsors and Collaborators
Javelin Pharmaceuticals
Investigators
Principal Investigator: Douglas G Stoker, DPM Jean Brown Research

Responsible Party: Amy Cohen/Director, Clinical Operations, Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00388011     History of Changes
Other Study ID Numbers: MOR-002
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: January 14, 2008
Last Verified: January 2008

Keywords provided by Javelin Pharmaceuticals:
Post surgical pain
Bunionectomy
Hammer Toe Syndrome
Morphine

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents