Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
This study has been completed.
Sponsor:
Alkermes
Information provided by (Responsible Party):
Alkermes
ClinicalTrials.gov Identifier:
NCT00945763
First received: July 23, 2009
Last updated: November 28, 2011
Last verified: November 2011
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Purpose
To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Pain |
Drug: N1539 Drug: placebo Drug: Motrin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Adaptive Design, Single-Dose Study of Intravenous N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery |
Resource links provided by NLM:
Further study details as provided by Alkermes:
Primary Outcome Measures:
- Pain Intensity Difference at End of Study [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Onset of action [ Time Frame: 0-1 hour ] [ Designated as safety issue: No ]
| Enrollment: | 230 |
| Study Start Date: | July 2009 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: placebo |
Drug: placebo
tablets
Other Name: sugar pill
|
| Experimental: N1539 15 mg |
Drug: N1539
15 mg
Other Name: meloxicam
|
| Experimental: N1539 30 mg |
Drug: N1539
30 mg
Other Name: meloxicam
|
| Experimental: N1539 60 mg |
Drug: N1539
60 mg
Other Name: meloxicam
|
| Active Comparator: Motrin |
Drug: Motrin
400 mg
Other Name: ibuprofen
|
Detailed Description:
This is a randomized, double-blind, placebo-controlled, single center study in subjects who have undergone third molar extraction surgery. Eligible subjects will have surgical removal of >2 third molars, of which at least 1 must be a complete or partial mandibular impaction. Each subject's study participation will consist of a screening visit (1-21 days prior to surgery), an inpatient evaluation period of 24 hours following dosing, and a follow-up phone call 3-5 days postdose.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- surgical extraction of > 2 third molars with at least 1 complete or partial mandibular bony extraction
Exclusion Criteria:
- allergic response to aspirin, NSAIDs, acetaminophen or hydrocodone
- use of aspirin or other analgesics within 48 hours prior to surgery
- current or recent history of drug or alcohol abuse
- any medication for treatment of chronic pain
- clinically significant abnormality on screening laboratory test active or recent history of peptic ulcer disease or GI bleeding
- prior abdominal surgery, except uncomplicated appendectomy
- any other surgical procedure within 30 days before administration of study drug
- pregnancy or breastfeeding
- untreated hypertension; SBP > 140 mmHg or DBP > 95 mmHg
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945763
Locations
| United States, Utah | |
| Jean Brown Research | |
| Salt Lake City, Utah, United States, 84124 | |
Sponsors and Collaborators
Alkermes
Investigators
| Principal Investigator: | Steven Christensen, DDS | Jean Brown Research, Salt Lake City, UT 84124 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Alkermes |
| ClinicalTrials.gov Identifier: | NCT00945763 History of Changes |
| Other Study ID Numbers: | N1539-02 |
| Study First Received: | July 23, 2009 |
| Last Updated: | November 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Alkermes:
|
Dental Pain |
Additional relevant MeSH terms:
|
Tooth, Impacted Toothache Tooth Diseases Stomatognathic Diseases Facial Pain Pain Signs and Symptoms Ibuprofen Meloxicam Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013