Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction
Information source: Javelin Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Operative Pain; Third Molar Extraction
Intervention: 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 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Javelin Pharmaceuticals Official(s) and/or principal investigator(s):
Kyle Christensen, DDS, Principal Investigator, Affiliation: Jean Brown Associates, Inc.
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
Secondary outcome: Other measures of pain relief
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
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: September 2001
Ending date: November 2001
Last updated: December 28, 2007
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