Trial Outcomes & Findings for Comparison of One Morphine Sulfate Sustained-Release 200mg Capsule With Two 100 mg KADIAN Capsules Under Fasting Conditions (NCT NCT00759759)
NCT ID: NCT00759759
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
|
14
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
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
didn't return for period 2
|
1
|
0
|
|
Overall Study
Didn't receive drug in period 2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Comparison of One Morphine Sulfate Sustained-Release 200mg Capsule With Two 100 mg KADIAN Capsules Under Fasting 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
|
31.8 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
34 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
33 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 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 doseOutcome measures
| Measure |
Morphine Sulfate 200 mg SR Capsules by Alpharma
n=28 Participants
|
KADIAN® 100mg Caps by Alpharma
n=28 Participants
|
|---|---|---|
|
Maximum Plasma Morphine Concentration
|
42.8 ng/mL
Standard Deviation 14.3
|
46.8 ng/mL
Standard Deviation 15.8
|
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 doseOutcome measures
| Measure |
Morphine Sulfate 200 mg SR Capsules by Alpharma
n=28 Participants
|
KADIAN® 100mg Caps by Alpharma
n=28 Participants
|
|---|---|---|
|
Time of Maximum Plasma Morphine Concentration
|
9.50 hr
Full Range 3.89 • Interval 4.0 to 18.0
|
12.00 hr
Full Range 3.69 • Interval 6.0 to 18.0
|
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 doseOutcome measures
| Measure |
Morphine Sulfate 200 mg SR Capsules by Alpharma
n=28 Participants
|
KADIAN® 100mg Caps by Alpharma
n=28 Participants
|
|---|---|---|
|
Area Under the Curve to the Last Measurable Time Point for Plasma Morphine
|
795.0 hr*ng/mL
Standard Deviation 231.2
|
772.6 hr*ng/mL
Standard Deviation 192.4
|
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 doseOutcome measures
| Measure |
Morphine Sulfate 200 mg SR Capsules by Alpharma
n=28 Participants
|
KADIAN® 100mg Caps by Alpharma
n=28 Participants
|
|---|---|---|
|
Area Under the Curve to Infinity for Plasma Morphine
|
875.7 hr*ng/mL
Standard Deviation 282.0
|
847.5 hr*ng/mL
Standard Deviation 213.3
|
Adverse Events
Arm 1: Treatment A Followed by Treatment B
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm 2: Treatment B Followed by Treatment A
Serious events: 0 serious events
Other events: 10 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
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
16.7%
3/18 • Number of events 5
|
16.7%
3/18 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
3/18 • Number of events 3
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Vasovagal Symptoms
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Number of events 2
|
0.00%
0/18
|
|
Psychiatric disorders
Mood Altered
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
General disorders
Chills
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Nausea
|
22.2%
4/18 • Number of events 5
|
22.2%
4/18 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Dizziness
|
27.8%
5/18 • Number of events 5
|
11.1%
2/18 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Somnolence
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Tachycardia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
General disorders
Asthenia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18
|
11.1%
2/18 • Number of events 2
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place