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.

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.

Start Date01 Jul 2007

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

100 Clinical Results associated with ORG-28611

100 Translational Medicine associated with ORG-28611

100 Patents (Medical) associated with ORG-28611

Literatures (Medical) associated with ORG-28611

01 Aug 2009·Journal of PsychopharmacologyQ3 · MEDICINE

Pharmacodynamic and pharmacokinetic effects of the intravenously administered CB1 receptor agonist Org 28611 in healthy male volunteers

Q3 · MEDICINE

Article

Author: Kleijn, HJ ; Passier, PCCM ; van Gerven, JMA ; de Kam, ML ; Cohen, AF ; Zuurman, L

Abstract CB1/CB2 agonists are reported to have sedative, amnestic, analgesic and anti-emetic properties, which would make them ideal drugs for outpatient treatments under conscious sedation. The main objective of this in human study was to assess the sedative properties of Org 28611, a potent water-soluble CB1 agonist. Single ascending doses were administered during a slow 25 min infusion and after a 1 min bolus administration to healthy male volunteers. In addition, the pharmacokinetics, amnestic properties, postural stability, electro-encephalography, behavioural and cardiovascular effects were studied. Midazolam 0.1 mg/kg was used as a positive control. The pharmacokinetic parameters were proportional to dose. No effects were observed after intravenous administration of doses up to Org 28611 1 μg/kg. Dose-related effects were observed at higher doses. Although subjects reported subjective sedation after administration of Org 28611 3-10 μg/kg, the observed sedation was considerably less than after midazolam. Org 28611 is, therefore, not suitable for providing sedation for outpatient surgical procedures and doses above the maximum tolerated dose of 3 μg/kg (either administered as a slow infusion or a bolus dose) can cause untoward psychotropic effects.

100 Deals associated with ORG-28611

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Indication	Highest Phase	Country/Location	Organization	Date
Analgesia	Phase 2	-	Merck Sharp & Dohme Corp.	01 Jul 2007
Tooth, Impacted	Phase 2	-	Merck Sharp & Dohme Corp.	01 Jul 2007
Anesthesia	Phase 2	-	Schering-Plough Corp.	-

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