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Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction

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ClinicalTrials.gov Identifier: NCT00390312
Recruitment Status : Completed
First Posted : October 19, 2006
Last Update Posted : January 4, 2008
Sponsor:
Information provided by:
Javelin Pharmaceuticals

Brief Summary:
This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.

Condition or disease Intervention/treatment Phase
Post-Operative Pain Third Molar Extraction Drug: Intranasal Placebo Drug: Intranasal Morphine 15 mg Drug: Immediate Release Oral Morphine 60 mg Drug: Intravenous morphine Drug: Intranasal morphine 7.5 mg Drug: Oral placebo Drug: Intravenous placebo Phase 2

Detailed Description:
Diagnosis and Main Criteria for Inclusion: Dental outpatients undergoing the removal of 3 or more third molars (2 of which were required to be mandibular and both must be bony impacted third molars).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Single Dose Comparison of Analgesic Efficacy and Safety of Intranasal Morphine, Immediate Release Oral Morphine, Intravenous Morphine and Placebo in Postsurgical Dental Pain
Study Start Date : September 2001
Actual Primary Completion Date : November 2001
Actual Study Completion Date : November 2001

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 4
Intravenous morphine
Drug: Intravenous morphine
Intravenous morphine 7.5 mg

Experimental: 1
Intranasal morphine 7.5 mg
Drug: Intranasal morphine 7.5 mg
Intranasal morphine 7.5 mg

Experimental: 2
Intranasal morphine 15 mg
Drug: Intranasal Morphine 15 mg
Intranasal Morphine 15 mg

Active Comparator: 3
Oral morphine 60 mg
Drug: Immediate Release Oral Morphine 60 mg
Immediate Release Oral Morphine 60 mg

Placebo Comparator: 5
Intranasal placebo
Drug: Intranasal Placebo
Intranasal placebo

Placebo Comparator: 6
Oral placebo
Drug: Oral placebo
Oral placebo

Placebo Comparator: 7
Intravenous placebo
Drug: Intravenous placebo
Intravenous placebo




Primary Outcome Measures :
  1. Total pain relief (TOTPAR) at the 0-2 hour time interval calculated as the time-weighted sum of the Pain Relief (PR) scores for the time interval 0-2 hours [ Time Frame: 2 hours ]

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


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 18-40 years of age
  • Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars)
  • Moderate or severe pain within 6 hours of completion of surgery

Exclusion Criteria:

  • Other oral surgical procedures during the same session except the removal of supernumerary third molars
  • Evidence 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
  • Allergy to shellfish

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): NCT00390312


Sponsors and Collaborators
Javelin Pharmaceuticals
Investigators
Principal Investigator: Kyle Christensen, DDS Jean Brown Associates, Inc.

Responsible Party: Amy Cohen/Director, Clinical Operations, Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00390312     History of Changes
Other Study ID Numbers: MOR-001
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: January 4, 2008
Last Verified: December 2007

Keywords provided by Javelin Pharmaceuticals:
Post operative pain
Third molar extraction
Dental surgery
Morphine

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents