A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | August 2014 |
| End Date: | April 2015 |
A Randomized, Double-blind, Placebo- and Active-controlled Trial to Investigate the Single-dose Efficacy, Safety, and Pharmacokinetics of 250 and 1000 mg JNJ-10450232 in Postoperative Dental Pain
To assess the safety and effectiveness one dose of a new pain reliever medicine
(JNJ-10450232 at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or
acetaminophen 1000 mg after surgical removal of third molars. The primary endpoint will
evaluate pain relief effectiveness up to 6 hours after administration of the study drug.
(JNJ-10450232 at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or
acetaminophen 1000 mg after surgical removal of third molars. The primary endpoint will
evaluate pain relief effectiveness up to 6 hours after administration of the study drug.
This is a single-center, randomized, double-blind, placebo- and active-controlled, parallel
group study to evaluate the efficacy, safety and pharmacokinetic profile of JNJ-10450232,
administered as a single dose in capsules (250 or 1000 mg), over a 24 hour period after
molar extractions. Subjects will stay at the research center for ~24 hours after
administration of study drug. Healthy male subjects, ages 18 to 45 years inclusive, will be
screened by medical history, vital signs, an electrocardiogram (ECG), and clinical
laboratory tests. Eligible subjects will return to the clinic on the day of surgery and
complete baseline vital signs and clinical laboratory tests. They will undergo dental
extraction of a minimum of three third-molars and, if qualified, will be randomly assigned
to one of four study treatments for pain.
group study to evaluate the efficacy, safety and pharmacokinetic profile of JNJ-10450232,
administered as a single dose in capsules (250 or 1000 mg), over a 24 hour period after
molar extractions. Subjects will stay at the research center for ~24 hours after
administration of study drug. Healthy male subjects, ages 18 to 45 years inclusive, will be
screened by medical history, vital signs, an electrocardiogram (ECG), and clinical
laboratory tests. Eligible subjects will return to the clinic on the day of surgery and
complete baseline vital signs and clinical laboratory tests. They will undergo dental
extraction of a minimum of three third-molars and, if qualified, will be randomly assigned
to one of four study treatments for pain.
Inclusion Criteria:
- Subjects aged 18-45 years
- At least moderate dental pain assessed by a categorical scale pain intensity scale
and a score of at least 5 on the 11-point (0-10) pain intensity numerical rating
scale (PI-NRS) following surgical removal of three third-molars
Exclusion Criteria:
- Subjects who are not otherwise healthy
- Test positive for the urine drug screen
- Taking prohibited medications will not be allowed to participate in this study
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