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

Javelin Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Third Molar Extraction; Post-Operative Pain

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00390312

MOR-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 225 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

225 participants in 7 patient groups, including a placebo group

4

Active Comparator group

Description:

Intravenous morphine

Treatment:

Drug: Intravenous morphine

1

Experimental group

Description:

Intranasal morphine 7.5 mg

Treatment:

Drug: Intranasal morphine 7.5 mg

2

Experimental group

Description:

Intranasal morphine 15 mg

Treatment:

Drug: Intranasal Morphine 15 mg

3

Active Comparator group

Description:

Oral morphine 60 mg

Treatment:

Drug: Immediate Release Oral Morphine 60 mg

5

Placebo Comparator group

Description:

Intranasal placebo

Treatment:

Drug: Intranasal Placebo

6

Placebo Comparator group

Description:

Oral placebo

Treatment:

Drug: Oral placebo

7

Placebo Comparator group

Description:

Intravenous placebo

Treatment:

Drug: Intravenous placebo