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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

Page last updated: June 20, 2008

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