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

Sponsor

Javelin Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00390312

Collaborator

(none)

225

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.

Condition or Disease	Intervention/Treatment	Phase
Post-Operative Pain Third Molar Extraction	Drug: 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	Phase 2

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

225 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2001

Actual Primary Completion Date :

Nov 1, 2001

Actual Study Completion Date :

Nov 1, 2001

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 4 Intravenous morphine	Drug: Intravenous morphine Intravenous morphine 7.5 mg
Experimental: 1 Intranasal morphine 7.5 mg	Drug: Intranasal morphine 7.5 mg Intranasal morphine 7.5 mg
Experimental: 2 Intranasal morphine 15 mg	Drug: Intranasal Morphine 15 mg Intranasal Morphine 15 mg
Active Comparator: 3 Oral morphine 60 mg	Drug: Immediate Release Oral Morphine 60 mg Immediate Release Oral Morphine 60 mg
Placebo Comparator: 5 Intranasal placebo	Drug: Intranasal Placebo Intranasal placebo
Placebo Comparator: 6 Oral placebo	Drug: Oral placebo Oral placebo
Placebo Comparator: 7 Intravenous placebo	Drug: Intravenous placebo Intravenous placebo

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

Other measures of pain relief [Several time points]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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