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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00390312
Other study ID # MOR-001
Secondary ID
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


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
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