Trial Outcomes & Findings for Comparison of One Morphine Sulfate Sustained-Release 200mg Capsule With Two 100 mg KADIAN Capsules Under Fed Conditions (NCT NCT00759356)

NCT ID: NCT00759356

Last Updated: 2010-08-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 36 participants
• Primary outcome timeframe: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose
• Results posted on: 2010-08-17

Participant Flow

Wash out period of at least 7 days.

Participant milestones

Measure	Period 1: Treatment A or B Treatment A (test product) followed by Treatment B (reference product)	Period 2: Treatment A or B Treatment B (reference product) followed by Treatment A (test product)
Overall Study STARTED	18	18
Overall Study COMPLETED	17	15
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Period 1: Treatment A or B Treatment A (test product) followed by Treatment B (reference product)	Period 2: Treatment A or B Treatment B (reference product) followed by Treatment A (test product)
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	0	2
Overall Study Subject was unable to return	1	0

Baseline Characteristics

Comparison of One Morphine Sulfate Sustained-Release 200mg Capsule With Two 100 mg KADIAN Capsules Under Fed Conditions

Baseline characteristics by cohort

Measure	Period 1: Treatment A or B n=18 Participants Treatment A (test product) followed by Treatment B (reference product)	Period 2: Treatment A or B n=18 Participants Treatment B (reference product) followed by Treatment A (test product)	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	29.5 years STANDARD_DEVIATION 7.5 • n=5 Participants	33.9 years STANDARD_DEVIATION 6.3 • n=7 Participants	31.7 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	18 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose

Outcome measures

Measure	Morphine Sulfate SR 200 mg Capsule n=28 Participants	KADIAN® 200 mg Capsule n=28 Participants
Mean Maximum Plasma Morphine Concentration	37.3 ng/mL Standard Deviation 15.8	32.8 ng/mL Standard Deviation 11.6

SECONDARY outcome

Timeframe: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose

Outcome measures

Measure	Morphine Sulfate SR 200 mg Capsule n=28 Participants	KADIAN® 200 mg Capsule n=28 Participants
Time of Maximum Plasma Morphine Concentration	12.00 hr Full Range 4.95 • Interval 8.0 to 24.0	12.00 hr Full Range 6.25 • Interval 8.0 to 30.0

SECONDARY outcome

Timeframe: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose

Outcome measures

Measure	Morphine Sulfate SR 200 mg Capsule n=28 Participants	KADIAN® 200 mg Capsule n=28 Participants
Area Under the Curve to the Last Measurable Time Point for Plasma Morphine	691.3 hr*ng/mL Standard Deviation 196.0	674.1 hr*ng/mL Standard Deviation 169.7

SECONDARY outcome

Timeframe: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose

Outcome measures

Measure	Morphine Sulfate SR 200 mg Capsule n=28 Participants	KADIAN® 200 mg Capsule n=28 Participants
Area Under the Curve to Infinity for Plasma Morphine	800.3 hr*ng/mL Standard Deviation 220.9	789.2 hr*ng/mL Standard Deviation 237.5

Adverse Events

Arm 1: Treatment A Followed by Treatment B

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Arm 2: Treatment B Followed by Treatment A

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm 1: Treatment A Followed by Treatment B	Arm 2: Treatment B Followed by Treatment A
Nervous system disorders Somnolence	16.7% 3/18 • Number of events 3	5.6% 1/18 • Number of events 1
Gastrointestinal disorders Abdominal Pain	22.2% 4/18 • Number of events 4	5.6% 1/18 • Number of events 2
Gastrointestinal disorders Nausea	38.9% 7/18 • Number of events 10	44.4% 8/18 • Number of events 9
Nervous system disorders Headache	11.1% 2/18 • Number of events 5	33.3% 6/18 • Number of events 6
Gastrointestinal disorders Vomiting	16.7% 3/18 • Number of events 3	16.7% 3/18 • Number of events 3
General disorders Fatigue	5.6% 1/18 • Number of events 1	0.00% 0/18
Vascular disorders Flushing	5.6% 1/18 • Number of events 1	0.00% 0/18
Infections and infestations Rhinitis	5.6% 1/18 • Number of events 1	0.00% 0/18
Respiratory, thoracic and mediastinal disorders Sneezing	5.6% 1/18 • Number of events 1	0.00% 0/18
Nervous system disorders Tremors	5.6% 1/18 • Number of events 1	0.00% 0/18
Gastrointestinal disorders Abdominal Distention	5.6% 1/18 • Number of events 1	0.00% 0/18
Psychiatric disorders Anxiety	0.00% 0/18	5.6% 1/18 • Number of events 1
Gastrointestinal disorders Dyspepsia	0.00% 0/18	5.6% 1/18 • Number of events 1
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/18	5.6% 1/18 • Number of events 1
Gastrointestinal disorders Diarrhea	0.00% 0/18	11.1% 2/18 • Number of events 2
General disorders Chills	0.00% 0/18	5.6% 1/18 • Number of events 1

Additional Information

Meena Venugopal, Director, Clinical R&D

Actavis Inc.

Phone: 908-659-2885

Email: MVenugopal@actavis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place