Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction
NCT00390312 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 225
Last updated 2008-01-04
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.
Conditions
- Post-Operative Pain
- Third Molar Extraction
Interventions
- DRUG
-
Intranasal Placebo
Intranasal placebo
- DRUG
-
Intranasal Morphine 15 mg
Intranasal Morphine 15 mg
- DRUG
-
Immediate Release Oral Morphine 60 mg
Immediate Release Oral Morphine 60 mg
- DRUG
-
Intravenous morphine
Intravenous morphine 7.5 mg
- DRUG
-
Intranasal morphine 7.5 mg
Intranasal morphine 7.5 mg
- DRUG
-
Oral placebo
Oral placebo
- DRUG
-
Intravenous placebo
Intravenous placebo
Sponsors & Collaborators
-
Javelin Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Kyle Christensen, DDS · Jean Brown Associates, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-09-30
- Primary Completion
- 2001-11-30
- Completion
- 2001-11-30
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