Status:
COMPLETED
Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction
Lead Sponsor:
Javelin Pharmaceuticals
Conditions:
Post-Operative Pain
Third Molar Extraction
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
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) ...
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2001
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT00390312
Start Date
September 1 2001
End Date
November 1 2001
Last Update
January 4 2008
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