Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period for this in-patient, multicenter study occurred between 04 September 2007 and 11 December 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial consisted of a Screening Period (Day -28 up to the first surgical incision on Day -1), a Surgical Period (Day -1 to Day 1 at approximately 03:00 h.), a Qualification Period (Day 1), a Double-Blind Treatment Period (Day 1 up to Day 4), and a Follow-up Period (Day 8 up to Day 18).

Reporting Groups

	Description
CG5503	CG5503 IR 75mg 4-6 hourly
Morphine	Morphine IR 30mg 4 to 6 hourly
Placebo	Matching Placebo 4 to 6 hourly

Participant Flow:   Overall Study

	CG5503	Morphine	Placebo
STARTED	96	96	99
COMPLETED	94	90	95
NOT COMPLETED	2	6	4
Withdrawal by Subject	0	1	1
Adverse Event	2	3	1
Lack of Efficacy	0	2	2

Reporting Groups

	Description
CG5503	CG5503 IR 75mg 4-6 hourly
Morphine	Morphine IR 30mg 4 to 6 hourly
Placebo	Matching Placebo 4 to 6 hourly

Baseline Measures

	CG5503	Morphine	Placebo	Total
Number of Participants   [units: participants]	96	96	99	291
Age   [units: participants]
<=18 years	0	1	1	2
Between 18 and 65 years	94	88	90	272
>=65 years	2	7	8	17
Age   [units: years] Mean ± Standard Deviation	44.6 ± 12.58	43.7 ± 14.19	43.8 ± 13.93	44.0 ± 13.55
Gender   [units: participants]
Female	83	73	88	244
Male	13	23	11	47
Region of Enrollment   [units: participants]
United States	96	96	99	291

1.  Primary:

Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.   [ Baseline value to 48 hours after first study drug intake. ]

2.  Secondary:

Number of Participants Using Rescue Medication   [ Baseline up to 72 hours after first study drug intake ]

3.  Secondary:

Total Pain Relief (TOTPAR)   [ Baseline to 48 hours after first study drug intake ]

4.  Secondary:

Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity   [ Baseline to 6 hours after intake of first study drug ]

5.  Secondary:

Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity   [ Baseline to 12 hours after first study drug intake ]

6.  Secondary:

Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity   [ Baseline to 24 hours after first study drug intake ]

7.  Secondary:

Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity   [ Baseline to 72 hours after first intake of study drug ]