- Patients had required an elective, non-urgent laparoscopic cholecystectomy, as an
outpatient procedure, with ASA Class I-III, with a Baseline Pain Intensity of moderate
or severe on a categorical scale and ≥45 mm on a VAS (100 mm)
- Patients were able to get their first dose of study medication within 8 hours after
the end of surgery
- Patients could not undergo procedures expected to produce a greater degree of surgical
trauma than the laparoscopic cholecystectomy alone, nor have acute pre-operative pain
(other than biliary colic) nor chronic pain conditions, nor uncontrolled chronic
conditions, nor cancer, nor a laboratory abnormality that the investigator considered
to contraindicate study participation
- Patient had any cognitive impairment that would, in the investigator's opinion,
preclude study participation or compliance with protocol mandated procedures
- Patient had a history of known alcohol, analgesic, or narcotic substance abuse within
the one year prior to Screening
- Patient had any laboratory abnormality at screening, that, in the opinion of the
investigator, is not due to the condition requiring surgery and is not expected to
resolve post-surgery, and would, therefore, contraindicate study participation