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

This study has been completed.
Sponsor:
Information provided by:
Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00390312
First received: October 17, 2006
Last updated: December 28, 2007
Last verified: December 2007
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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

Enrollment: 225
Study Start Date: September 2001
Study Completion Date: November 2001
Primary Completion Date: November 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390312

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

No publications provided

Responsible Party: Amy Cohen/Director, Clinical Operations, Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00390312     History of Changes
Other Study ID Numbers: MOR-001
Study First Received: October 17, 2006
Last Updated: December 28, 2007
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 27, 2014