Trial Outcomes & Findings for Comparison of One Morphine Sulfate Sustained-Release 200 mg Capsule With Two 100 mg KADIAN Capsules on Applesauce (NCT NCT00759954)
NCT ID: NCT00759954
Last Updated: 2010-08-17
Results Overview
calculated from drug concentration over time
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
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
Participants were recruited from general public. The signed consent forms were obtained during the period of September 7 - 13, 2004.
Wash out period was 7 days. No enrolled participants were excluded from the trial before assignment to groups
Participant milestones
| Measure |
Period 1: Treatment A or B
Treatment A (test product) followed by Treatment B (reference product)
|
Period 2: Treatment Aor B
Treatment B (reference product)followed by Treatment A (test product)
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Period 1: Treatment A or B
Treatment A (test product) followed by Treatment B (reference product)
|
Period 2: Treatment Aor B
Treatment B (reference product)followed by Treatment A (test product)
|
|---|---|---|
|
Overall Study
Personal reason
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
2
|
Baseline Characteristics
Comparison of One Morphine Sulfate Sustained-Release 200 mg Capsule With Two 100 mg KADIAN Capsules on Applesauce
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 Aor 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
|
26.50 years
STANDARD_DEVIATION 5.93 • n=5 Participants
|
29.61 years
STANDARD_DEVIATION 8.81 • n=7 Participants
|
28.06 years
STANDARD_DEVIATION 7.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 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: 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dosecalculated from drug concentration over time
Outcome measures
| Measure |
Morphine Sulfate 200 mg SR Caps by Alpharma
n=28 Participants
|
KADIAN® 2 × 100 mg Caps by Alpharma
n=28 Participants
|
|---|---|---|
|
Maximum Plasma Morphine Concentration
|
37.5 ng/mL
Standard Deviation 16.8
|
38.0 ng/mL
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dosePopulation: Subjects completed the study without protocol violations.
calculated from drug concentration over time
Outcome measures
| Measure |
Morphine Sulfate 200 mg SR Caps by Alpharma
n=28 Participants
|
KADIAN® 2 × 100 mg Caps by Alpharma
n=28 Participants
|
|---|---|---|
|
Time of Maximum Plasma Morphine Concentration
|
10.50 hour
Full Range 3.91 • Interval 6.0 to 24.0
|
9.25 hour
Full Range 5.21 • Interval 6.0 to 30.0
|
SECONDARY outcome
Timeframe: 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dosecalculated from drug concentration over time
Outcome measures
| Measure |
Morphine Sulfate 200 mg SR Caps by Alpharma
n=28 Participants
|
KADIAN® 2 × 100 mg Caps by Alpharma
n=28 Participants
|
|---|---|---|
|
Area Under the Curve to the Last Measurable Time Point for Plasma Morphine
|
717.3 ng*hr/mL
Standard Deviation 213.2
|
744.1 ng*hr/mL
Standard Deviation 195.0
|
SECONDARY outcome
Timeframe: 0, 2, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 12, 18, 24, 30, 36, and 48 hrs post doseOutcome measures
| Measure |
Morphine Sulfate 200 mg SR Caps by Alpharma
n=28 Participants
|
KADIAN® 2 × 100 mg Caps by Alpharma
n=28 Participants
|
|---|---|---|
|
Area Under the Curve to Infinity for Plasma Morphine
|
800.7 ng*hr/mL
Standard Deviation 232.6
|
814.5 ng*hr/mL
Standard Deviation 222.5
|
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
Abdominal pain
|
11.1%
2/18 • Number of events 2
|
11.1%
2/18 • Number of events 4
|
|
Nervous system disorders
Solmnolence
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Number of events 3
|
16.7%
3/18 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
2/18 • Number of events 3
|
22.2%
4/18 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
27.8%
5/18 • Number of events 5
|
38.9%
7/18 • Number of events 7
|
|
Renal and urinary disorders
Micturition Urgency
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
General disorders
Chest pain
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
General disorders
Chest discomfort
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Rhinitis
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18
|
11.1%
2/18 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Nervousness
|
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