Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390312
• Other study ID #: MOR-001
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2006
• Last updated: December 28, 2007
• Start date: September 2001
• Est. completion date: November 2001

Study information

• 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

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-Operative Pain
• Third Molar Extraction

Intervention

Drug:
• Intranasal Placebo
Intranasal placebo
• Intranasal Morphine 15 mg
Intranasal Morphine 15 mg
• Immediate Release Oral Morphine 60 mg
Immediate Release Oral Morphine 60 mg
• Intravenous morphine
Intravenous morphine 7.5 mg
• Intranasal morphine 7.5 mg
Intranasal morphine 7.5 mg
• Oral placebo
Oral placebo
• Intravenous placebo
Intravenous placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Javelin Pharmaceuticals

Outcome

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