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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00782951 |
Patients will receive a single intravenous (IV) infusion administered over 3 minutes of either ORG 28611 (SCH 900111), 0.12 mg/kg morphine sulphate, or placebo, within 6 hours after dental surgery, when they experience moderate to severe dental pain. Patient will then be evaluated with pain assessments at Baseline, 5, 10, 15, 30, 45, 60, and 90 minutes; and 2 through 8 hours or before rescue medication is needed.
Condition | Intervention | Phase |
---|---|---|
Analgesia |
Drug: Org 28611 Drug: morphine sulfate Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Active and Placebo Controlled Trial to Compare the Relative Analgesic Efficacy and Safety of a Single Intravenous Dose of ORG 28611 3 Mcg/kg, Morphine Sulfate 0.12 mg/kg, and Placebo in Patients Experiencing Moderate to Severe Pain After Dental Impaction Surgery. |
Enrollment: | 11 |
Study Start Date: | July 2007 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Org 28611: Experimental |
Drug: Org 28611
single IV dose of Org 28611 3 mcg/kg after dental impaction surgery
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morphine sulfate: Active Comparator |
Drug: morphine sulfate
single IV dose of morphine sulfate 0.12 mg/kg after dental impaction surgery
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Placebo: Placebo Comparator |
Drug: Placebo
single IV dose of placebo after dental impaction surgery
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Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Has an abnormal clinically significant EEG and/or an EEG indicating possible seizure(-like) disorder according to the following abnormalities (with or without clinical significance):
Responsible Party: | NV Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | P05800, Study 231006;, EudraCT Number: 2006-002571-40 |
Study First Received: | October 30, 2008 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00782951 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Morphine Tooth Diseases Pain Stomatognathic Diseases Tooth, Impacted |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |