| October 17, 2006 |
| December 28, 2007 |
| September 2001 |
| November 2001 (final data collection date for primary outcome measure) |
| 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 [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ] |
| Time specific Pain Intensity Difference (PID) from baseline Visual Analog Scale (VAS) |
| Complete list of historical versions of study NCT00390312 on ClinicalTrials.gov Archive Site |
| Other measures of pain relief [ Time Frame: Several time points ] [ Designated as safety issue: Yes ] |
| Other measures of pain relief |
| |
| Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction |
| 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 |
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. |
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). |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
- 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
|
- Active Comparator: Intravenous morphine
- Experimental: Intranasal morphine 7.5 mg
- Experimental: Intranasal morphine 15 mg
- Active Comparator: Oral morphine 60 mg
- Placebo Comparator: Intranasal placebo
- Placebo Comparator: Oral placebo
- Placebo Comparator: Intravenous placebo
|
| |
| |
| Completed |
| 225 |
| November 2001 |
| November 2001 (final data collection date for primary outcome measure) |
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 |
| Both |
| 18 Years to 40 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00390312 |
| Amy Cohen/Director, Clinical Operations, Javelin Pharmaceuticals |
| MOR-001 |
| Javelin Pharmaceuticals |
|
| Principal Investigator: |
Kyle Christensen, DDS |
Jean Brown Associates, Inc. |
|
|
| Javelin Pharmaceuticals |
| December 2007 |
