Trial Profile
A Single-dose, Double-blind, Double-dummy, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of Dronabinol Oral Solution in Recreational Cannabinoid Users
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 04 Jun 2015
Price :
$35
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At a glance
- Drugs Dronabinol (Primary)
- Indications Anorexia; Chemotherapy-induced nausea and vomiting
- Focus Adverse reactions
- Sponsors INSYS Therapeutics, Inc
- 02 Jun 2015 According to an Insys Therapeutics media release, a New Drug Application has been re-submitted to the US FDA. Earlier a 'Refusal to File' letter was received in October 2014 for previously submitted NDA due to inadequate or incomplete pediatric study plan.
- 12 May 2014 Status changed from not yet recruiting to completed as reported by ClinicalTrials.gov
- 27 Mar 2014 New trial record