Post-Operative Pain Clinical Trial
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
Verified date | December 2007 |
Source | Javelin Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 225 |
Est. completion date | November 2001 |
Est. primary completion date | November 2001 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Javelin Pharmaceuticals |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 2 hours | Yes | |
Secondary | Other measures of pain relief | Several time points | Yes |
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